[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Rules and Regulations]
[Pages 59222-59231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-29189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 876, 880, 882, 886, 890, and 892

[Docket No. 98-0015]


Medical Devices; Exemptions From Premarket Notification; Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is codifying the 
exemption from premarket notification of all 62 class II (special 
controls) devices listed as exempt in a January 21, 1998, Federal 
Register notice, subject to the limitations on exemptions. FDA has 
determined that for these exempted devices, manufacturers' submissions 
of premarket notifications are unnecessary to provide a reasonable 
assurance of safety and effectiveness. These devices will remain 
subject to current good manufacturing practice (CGMP) regulations and 
other general controls. This rulemaking implements new authorities 
delegated to FDA under the Food and Drug Administration Modernization 
Act (FDAMA).
EFFECTIVE DATE: November 3, 1998.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 21, 1998 (63 FR 3142) 
(hereinafter referred to as the January 21, 1998, notice), FDA issued a 
notice stating that 62 class II (special controls) devices were exempt 
from the requirement of premarket notification, with limitations. This 
notice was issued in accordance with FDAMA (Pub. L. 105-115), which the 
President signed into law on November 21, 1997. Section 206 of FDAMA, 
in part, added a new section 510(m) to the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360(m)). Section 510(m)(1) of the act 
required FDA, within 60 days after enactment of FDAMA, to publish in 
the Federal Register a list of each type of class II device that does 
not require a report under section 510(k) of the act (generally 
referred to as a premarket notification or ``510(k)'') to provide 
reasonable assurance of safety and effectiveness. Section 510(m) of the 
act further provided that a 510(k) will no longer be required for these 
devices upon the date of publication of the list in the Federal 
Register. Interested persons were given until April 20, 1998, to 
comment on the notice.
    Section 510(m)(2) of the act also provides that, 1 day after date 
of publication of the list under section 510(m)(1) FDA may exempt a 
device on its own initiative or upon petition of an interested person, 
if FDA determines that a 510(k) is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device.
    An exemption from the requirement of premarket notification does 
not mean that the device is exempt from any other statutory or 
regulatory requirements, unless such exemption is explicitly provided 
by order or regulation. Indeed, FDA's determination that premarket 
notification was unnecessary to provide a reasonable assurance of 
safety and effectiveness for devices listed in this document was based, 
in part, on the assurance of safety and effectiveness that other 
regulatory controls, such as current good manufacturing practice 
requirements, provide. Persons with pending 510(k) submissions for 
devices that are now exempt from premarket notification, subject to the 
limitations on exemptions, should withdraw their submissions.
    FDA is codifying the exemption from premarket notification of all 
62 class II devices listed as exempt in the January 21, 1998, notice, 
subject to the limitations on exemptions. These devices will remain 
subject to CGMP requirements and other general controls under the 
statute as well as any special controls.
    The Administrative Procedure Act (the APA) (Pub. L. 79-404) and FDA 
regulations provide that the agency may issue a regulation without 
notice and comment procedures when the agency for good cause finds (and 
incorporates the finding and a brief statement of reasons thereof in 
the rules issued) that notice and public procedure thereon are 
impracticable, unnecessary, or contrary to the public interest (5 
U.S.C. 553(b)(8), Sec. 10.40(e)(1) (21 CFR 10.40).) The Commissioner of 
Food and Drugs (the Commissioner) finds for good cause that there is 
reason to dispense with notice and comment rulemaking to amend the 
codified language in the Code of Federal Regulations (CFR) to reflect 
that certain class II devices are exempt.
    Notice and comment rulemaking to codify the exemptions for these 
class II devices would be both impracticable and unnecessary. As 
previously stated, under the authority provided by section 206 of 
FDAMA, these exemptions have already taken effect by operation of the 
statute on January 21, 1998. Accordingly, it is both impracticable and 
unnecessary to provide notice and comment on a regulation that merely 
codifies that which has already occurred. Furthermore, interested 
persons were provided an opportunity to comment when the January 21, 
1998, notice published.

II. Effective Date

    Section 553(d) of the APA requires that the effective date of a 
substantive rule shall occur not less than 30 days after the 
publication or service unless, under section 553(d)(1), the rule grants 
or recognizes an exemption or relieves a restriction, or unless, under 
section 553(d)(3), the agency finds good cause to make the effective 
date less than 30 days and publishes the basis with the rule.
    The Commissioner finds that because the exemptions are already in 
effect, providing a delayed effective date for the regulation 
conforming the CFR to reflect the exemptions is impracticable and 
unnecessary. Accordingly, there is good cause, under section 553(d)(3) 
of the APA and Sec. 10.40(c)(4)(ii), to provide an immediate effective 
date. Additionally, an immediate effective date is authorized under 
section 553(d)(1) and Sec. 10.40(c)(4)(i) because the codification of 
the exemptions recognizes an exemption.

III. Comments

    FDA received 8 sets of comments from respondents, both supporting 
and opposing the exemption of the 62 class II devices.
    1. Two comments suggested that FDA remove the following in vitro 
diagnostic, class II devices from the list of exempted devices: 21 CFR 
866.3060 Blastomyces dermatitidis, 866.3085 Brucella spp. serological 
reagents, 866.3135 Coccidioides immitis serological reagents, 866.3320 
Histoplasma capsulatum serological reagents, 866.3165 Crytococcus

[[Page 59223]]

neoformans serological reagents, 866.3220 Entamoeba histoloytica 
serological reagents, 866.3280 Franciscella tularensis serological 
reagents, 866.3350 Leptospira spp. serological reagents, and 866.3460 
Rabiesvirus immunofluorescent reagents. The comments stated that these 
devices fail to meet the criteria for exemption as described in the 
regulatory notice as ``Limitations on Exemptions.'' Also, a third 
comment suggested that two ``in vitro devices * * * intended for the 
screening of familial and acquired genetic disorders''(21 CFR 866.5210 
Ceruloplasmin immunological test system and 866.5470 Hemoglobin 
immunological test system) fail to meet criteria for exemption under 
FDAMA.
    Devices that are listed as exempt from 510(k) requirements are 
subject to the limitations to those exemptions described in the January 
21, 1998, notice. The limitations to the exemptions state that for 
certain uses, in vitro diagnostic devices that are otherwise exempt are 
still subject to 510(k) requirements. Accordingly, a generic device 
type may be exempt from 510(k) requirements for some uses, and not 
exempt from those requirements if it is intended for other uses 
described in the limitations language. For example, the January 21, 
1998, notice states that a generic type of device that is otherwise 
exempt is not exempt if it is used in screening or diagnosis of 
familial and acquired genetic disorders, or for measuring analytes that 
serve as a surrogate marker for screening, diagnosis, or monitoring 
life-threatening diseases.
    FDA does not agree that all the marketed uses for the devices 
addressed by the comments (with the exceptions of rabiesvirus 
immunofluorescent reagents, the ceruloplasmin immunological test 
system, and the hemoglobin immunological test system) fall within the 
limitations to the exemptions language in the January 21, 1998, notice. 
These devices can be exempt, for example, when they are marketed for 
the determination of immune status, or for epidemiological uses. If 
these same devices, however, are used in the diagnosis of a life-
threatening disease, they would not be exempt.
    FDA agrees, however, that all marketed uses for rabiesvirus 
immunofluorescent reagents are for the detection of rabies, a life-
threatening disease, and that all marketed uses for the ceruloplasmin 
immunological test system and the hemoglobin immunological test system 
are for the screening or diagnosis of familial and acquired genetic 
disorders. Accordingly, all intended uses for these devices would fall 
within the limitations to exemptions for devices that are for use in 
screening or diagnosis of familial and acquired genetic disorders, or 
for measuring analytes that serve as surrogate markers for screening, 
diagnosis, or monitoring life-threatening diseases.
    FDA believes that it erroneously listed the generic device types 
rabiesvirus immunofluorescent reagents, ceruloplasmin immunological 
test systems, and hemoglobin immunological test systems as exempt from 
510(k) requirements in the January 21, 1998, notice. Therefore, FDA 
intends to issue a proposal to clarify that none of these devices are 
exempt from 510(k) requirements. Until such rulemaking is final, 
however, these devices will be listed, in accordance with the January 
21, 1998, notice, as exempt subject to the limitations to the 
exemptions. Sponsors should be aware, however, that FDA believes that 
all marketed uses for these devices fall within the limitations to the 
exemptions, and that sponsors, therefore, should continue to submit 
510(k) submissions.
    2. One comment requested more information on devices covered by 21 
CFR 864.9160 Blood group substances of nonhuman origin for in vitro 
diagnostic use.
    FDA believes that devices in this classification traditionally have 
been used for neutralization studies to assist in identification of 
antibodies in patients with multiple antibodies. There does not appear 
to be a high demand for these devices. FDA believes that there are 
quality control practices and procedures in place that make continued 
active premarket regulation unnecessary to ensure safety and 
effectiveness.
    3. The Health Care Financing Administration (HCFA) raised concerns 
about the effect that exemptions may have on HCFA's implementation of 
the Clinical Laboratory Improvements Amendments. HCFA subsequently 
commented that they believed that their concerns could be addressed 
without affecting the exemption process.
    FDA intends to continue to meet with the HCFA staff to address 
these concerns, which relate to inspection procedures in laboratories.
    4. One comment questioned the limitations on exemptions stated in 
the January 21, 1998, notice, particularly the limitations applicable 
to in vitro diagnostic devices that are noninvasive tests. The comment 
criticized the use of the words ``noninvasive testing'' as being overly 
broad.
    FDA disagrees with this comment. FDA believes that the limitations 
are necessary to ensure that devices are not marketed that are 
significantly different from the devices exempted from premarket 
notification, particularly in the area of in vitro diagnostic devices 
where devices are often subject to changes in intended use and 
conditions of use. Noninvasive testing devices should not be exempt 
because they almost always involve novel matrices and novel 
technologies.
    5. One comment suggested that the limitations on exemptions are 
unnecessary, confusing, and difficult to apply, especially to in vitro 
diagnostic devices. This comment additionally notes ``we question the 
basis for FDA's broad restrictions in such a specific category of 
devices.''
    FDA does not agree that the language is unnecessary, confusing, or 
difficult to apply. The limitations language in the January 21, 1998, 
notice, that applies to class II devices listed therein, modifies the 
limitations on exemptions currently found in ``.9'' of each device 
classification regulation part (e.g., 21 CFR 862.9, 864.9, etc.) only 
in three ways. First, FDA has referenced class II devices to reflect 
that class II devices may be exempted in accordance with new section 
510(m) of the act. Second, the limitations language modifies current 
limitations language by stating that devices are to be compared to 
``any legally marketed device in that generic type of device'' rather 
than a device on the market ``before May 28, 1976'' or a 
``preamendments device to which it has been determined substantially 
equivalent.'' Third, the limitations language adds specific language 
relating to in vitro diagnostic devices. The agency cannot predict all 
possible different intended uses or changes in fundamental scientific 
technologies that may significantly affect safety and effectiveness; 
limitations on exemptions are, therefore, in the best interest of the 
public health because they ensure that devices incorporating such 
changes will be reviewed for safety and effectiveness by the agency 
before they go to market. Furthermore, FDA believes that in vitro 
diagnostic devices are unique because their safety and effectiveness 
relates primarily to the information generated by these devices rather 
than the direct interaction between device and patient. FDA has more 
fully discussed the need for these limitations in the January 21, 1998, 
notice. In order to efficiently allocate review resources, the agency 
has developed a risk-based approach toward use of the limitations on 
exemptions to ensure that high-risk devices remain subject to premarket 
review. The limitations on exemptions continue to take into account two

[[Page 59224]]

critical risk elements: Intended use and novelty of technology.
    6. One comment stated that body fat testers meet the criteria for 
exemption from 510(k) and should therefore be exempt. Another comment 
stated that film dosimetry systems are quality control devices and 
should not be regulated as a class II device.
    Neither of these devices were listed as exempt in the January 21, 
1998, notice. Body fat analyzers have been found to be substantially 
equivalent to legally marketed devices classified under 21 CFR 870.2770 
Impedance plethysmograph. Film dosimetry systems are regulated under 21 
CFR 892.5050 Medical charged-particle radiation therapy system. This 
document is codifying the exemptions only for devices listed in the 
January 21, 1998, notice.
    Under new section 510(m)(2) of the act, any person now may petition 
the agency for additional exemptions from the requirements of 510(k) 
for a class II device type. FDA has provided guidance for submitting a 
petition for exemption of a class II device and has requested that 
these comments submit such petitions for these device types.
    7. One comment believed the limitations on exemptions required 
clarification as follows:
    With regard to the first limitation (``has an intended use that 
is different from the intended use of a legally marketed device in 
that generic type''), we believe that current law is clear that if a 
device has an intended use different than that expressed in the 
definition contained in the Code of Federal Regulations (CFR), such 
device would not be the same as the exempted device. The exemption 
would simply not apply to that device. However, ``intended use'' can 
encompass many different concepts that go beyond the general 
intended use statements that comprised the CFR definitions. There 
has been some controversy, for instance, over the extent to which 
indications for use can change intended use. Our position is that 
any indication for use that has been included in a previous 510(k) 
order of classification identifies the scope of the intended use for 
each exempt type of device. Minor variances of indications for use 
within the intended use of an exempt type of device should have no 
effect on the status of a 510(k) exemption.
    FDA has interpreted paragraph``.9(a)'' of each device 
classification regulation part (e.g., 21 CFR 862.9, 864.9, etc.) in the 
limitations on exemptions under the current regulation to mean that any 
legally marketed device (as defined in 21 CFR 807.92(a)(3)) within a 
device classification regulation, may serve as a predicate for another 
manufacturer's device, and the other manufacturer's device may be 
exempt. FDA believes that any additional indication for use for an 
exempt classification device type (i.e., an indication not previously 
cleared) is considered a different intended use and does not meet the 
limitations on exemptions, and therefore, requires a new premarket 
notification. FDA agrees that minor variances in indications would not 
affect the exemption status of the classification. FDA notes that in 
our guidance entitled ``Deciding When to Submit a 510(k) for a Change 
to an Existing Device,'' FDA states, in regard to minor variances in 
indications of closely related populations, ``If the expansion is to a 
population with similar demographics, diagnosis, prognosis, comorbidity 
and potential for complications as the original, then a new 510(k) is 
not ordinarily expected.''

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment or an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive Order 
12866 directs agencies to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy on 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    If there is a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. Because this final rule would reduce a 
regulatory burden by exempting manufacturers of devices subject to the 
requirements of premarket notification, the agency certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance from the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects

21 CFR Parts 862, 876, 880, 882, and 890

    Medical devices.

21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

21 CFR Part 892

    Medical devices, Radiation protection, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drug, 21 CFR parts 
862, 864, 866, 876, 880, 882, 886, 890, and 892 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation 21 CFR part 862 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 862.9 is amended by revising the section heading, by 
designating the introductory text as paragraph (a), by redesignating 
paragraphs (a) and (b) as paragraphs (a)(1) and (a)(2), respectively, 
and by adding new paragraph (b) to read as follows:


Sec. 862.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with

[[Page 59225]]

high morbidity or mortality. A class II device for which FDA has 
granted an exemption from the requirement of premarket notification 
must still submit a premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For use in assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For use in identifying or inferring the identity of a 
microorganism directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    3. Section 862.1440 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1440  Lactate dehydrogenase test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.
    4. Section 862.1635 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1635  Total protein test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    5. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    6. Section 864.9 is amended by designating the introductory text as 
paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 864.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    7. Section 864.6100 is amended by revising paragraph (b) to read as 
follows:


Sec. 864.6100  Bleeding time device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    8. Section 864.6400 is amended by revising paragraph (b) to read as 
follows:


Sec. 864.6400  Hematocrit measuring device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    9. Section 864.9160 is amended by revising paragraph (b) to read as 
follows:


Sec. 864.9160  Blood group substance of nonhuman origin for in vitro 
diagnostic use.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    10. Section 864.9550 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9550  Lectins and protectins.

* * * * *

[[Page 59226]]

    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    11. Section 864.9575 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9575  Environmental chamber for storage of platelet 
concentrate.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    12. Section 864.9600 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9600  Potentiating media for in vitro diagnostic use.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.
    13. Section 864.9700 is amended by revising paragraph (b) to read 
as follows:


Sec. 864.9700  Blood storage refrigerator and blood storage freezer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    14. The authority citation for 21 CFR part 866 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    15. Section 866.9 is amended by designating the introductory text 
as paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 866.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    16. Section 866.3060 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3060  Blastomyces dermatitidis serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    17. Section 866.3085 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3085  Brucella spp. serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    18. Section 866.3135 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3135  Coccidioides immitis serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    19. Section 866.3165 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3165  Crytococcus neoformans serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    20. Section 866.3220 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3220  Entamoeba histolytica serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    21. Section 866.3280 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3280  Francisella tularensis serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    22. Section 866.3300 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3300  Haemophilus spp. serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    23. Section 866.3320 is amended by revising paragraph (b) to read 
as follows:

[[Page 59227]]

Sec. 866.3320  Histoplasma capsulatum serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    24. Section 866.3350 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3350  Leptospira spp. serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    25. Section 866.3415 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3415  Pseudomonas spp. serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    26. Section 866.3550 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3550  Salmonella spp. serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    27. Section 866.3660 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3660  Shigella spp. serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    28. Section 866.3930 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.3930  Vibrio cholerae serological reagents.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    29. Section 866.5040 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5040  Albumin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    30. Section 866.5320 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5320  Properdin factor B immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    31. Section 866.5380 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5380  Free secretory component immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    32. Section 866.5460 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5460  Haptoglobin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.
    33. Section 866.5490 is amended by revising paragraph (b) to read 
as follows:


Sec. 866.5490  Hemopexin immunological test system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    34. The authority citation for 21 CFR part 876 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    35. Section 876.9 is amended by designating the introductory text 
as paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 876.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganism other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).

[[Page 59228]]

    36. Section 876.1620 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.1620  Urodynamics measurement system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
    37. Section 876.1800 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.1800  Urine flow or volume measuring system.

* * * * *
    (b) Classification. (1) Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
* * * * *
    38. Section 876.2040 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 876.2040  Enuresis alarm.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
    39. Section 876.4370 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 876.4370  Gastroenterology-urology evacuator.

* * * * *
    (b) Classification. (1) Class II (special controls) for the 
gastroenterology-urology evacuator when other than manually powered. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to Sec. 876.9.
* * * * *
    40. Section 876.4650 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4650  Water jet renal stone dislodger system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
    41. Section 876.4680 is amended by revising paragraph (b) to read 
as follows:


Sec. 876.4680  Ureteral stone dislodger.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
    42. Section 876.4890 is amended by revising paragraph (b)(1) to 
read as follows:


Sec. 876.4890  Urological table and accessories.

* * * * *
    (b) Classification. (1) Class II (special controls) for the 
electrically powered urological table and accessories. The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
* * * * *
    43. Section 876.5250 is amended by revising paragraph (b)(1) to 
read as follows:

Sec. 876.5250  Urine collector and accessories.

* * * * *
    (b) Classification. (1) Class II (special controls) for a urine 
collector and accessories intended to be connected to an indwelling 
catheter. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 876.9.
* * * * *

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    44. The authority citation for 21 CFR 880 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    45. Section 880.9 is amended by designating the introductory text 
as paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 880.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    46. Section 880.2200 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.2200  Liquid crystal forehead temperature strip.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    47. Section 880.2920 is amended by revising paragraph (b) to read 
follows:


Sec. 880.2920  Clinical mercury thermometer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the

[[Page 59229]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 880.9.
    48. Section 880.5100 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5100  AC-powered adjustable hospital bed.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    49. Section 880.5140 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5140  Pediatric hospital bed.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    50. Section 880.5475 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5475  Jet lavage.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    51. Section 880.5500 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5500  AC-powered patient lift.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    52. Section 880.5550 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.5550  Alternating pressure air flotation mattress.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    53. Section 880.6740 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6740  Vacuum-powered body fluid suction apparatus.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures is subpart E of part 
807 of this chapter subject to Sec. 880.9.
    54. Section 880.6775 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6775  Powered patient transfer device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.
    55. Section 880.6910 is amended by revising paragraph (b) to read 
as follows:


Sec. 880.6910  Wheeled stretcher.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

PART 882--NEUROLOGICAL DEVICES

    56. The authority citation 21 CFR part 882 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    57. Section 882.9 is amended by designating the introductory text 
as paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 882.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    58. Section 882.5050 is amended by revising paragraph (b) to read 
as follows:


Sec. 882.5050  Biofeedback device.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter when it is a prescription battery powered device 
that is indicated for relaxation training and muscle reeducation and 
prescription use, subject to Sec. 882.9.

PART 886--OPHTHALMIC DEVICES

    59. The authority citation 21 CFR Part 886 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    60. Section 886.9 is amended by revising the section heading, by 
designating the introductory text as paragraph (a), by redesignating 
paragraphs (a) and (b) as paragraphs (a)(1) and (a)(2), respectively, 
and by adding new paragraph (b) to read as follows:

[[Page 59230]]

Sec. 886.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    61. Section 886.3100 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.3100  Ophthalmic tantalum clip.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.
    62. Section 886.3130 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.3130  Ophthalmic conformer.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.
    63. Section 886.3800 is amended by revising paragraph (b) to read 
as follows:


Sec. 886.3800  Scleral shell.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.

PART 890--PHYSICAL MEDICINE DEVICES

    64.The authority citation 21 CFR part 890 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    65. Section 890.9 is amended by designating the introductory text 
as paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 890.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) for detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    66. Section 890.1925 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.1925  Isokinetic testing and evaluation system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    67. Section 890.3500 is amended by revising paragraph (b) to read 
as follows:

[[Page 59231]]

Sec. 890.3500  External assembled lower limb prosthesis.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    68. Section 890.3710 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3710  Powered communication system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    69. Section 890.3725 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.3725  Powered environmental control system.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    70. Section 890.5160 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5160  Air-fluidized bed.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    71. Section 890.5170 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5170  Powered flotation therapy bed.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    72. Section 890.5225 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5225  Powered patient rotation bed.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    73. Section 890.5720 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5720  Water circulating hot or cold pack.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.
    74. Section 890.5740 is amended by revising paragraph (b) to read 
as follows:


Sec. 890.5740  Powered heating pad.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E part 807 
of this chapter subject to Sec. 890.9.

PART 892--RADIOLOGY DEVICES

    75. The authority citation for 21 CFR part 892 continues to read 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    76. Section 892.9 is amended by designating the introductory text 
as paragraph (a), by redesignating paragraphs (a) and (b) as paragraphs 
(a)(1) and (a)(2), respectively, and by adding new paragraph (b) to 
read as follows:


Sec. 892.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

* * * * *
    (b) The exemption from the requirement of premarket notification 
for a generic type of class II device applies only to those class II 
devices that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. A class II device for which FDA has granted an exemption 
from the requirement of premarket notification must still submit a 
premarket notification when:
    (1) The device is intended for a use different from the intended 
use of a legally marketed device in that generic type of device; e.g., 
the device is intended for a different medical purpose, or the device 
is intended for lay use where the former intended use was by health 
care professionals only; or
    (2) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro 
diagnostic device detects or identifies infectious agents by using 
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization 
technology rather than culture or immunoassay technology; or
    (3) The device is an in vitro device that is intended:
    (i) For use in the diagnosis, monitoring, or screening of 
neoplastic diseases with the exception of immunohistochemical devices;
    (ii) For use in screening or diagnosis of familial and acquired 
genetic disorders, including inborn errors of metabolism;
    (iii) For measuring an analyte that serves as a surrogate marker 
for screening, diagnosis, or monitoring life-threatening diseases such 
as acquired immune deficiency syndrome (AIDS), chronic or active 
hepatitis, tuberculosis, or myocardial infarction or to monitor 
therapy;
    (iv) For assessing the risk of cardiovascular diseases;
    (v) For use in diabetes management;
    (vi) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (vii) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) and IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is 
intended for use in matrices other than serum or plasma;
    (viii) For noninvasive testing; and
    (ix) For near patient testing (point of care).
    77. Section 892.1980 is amended by revising paragraph (b) to read 
as follows:


Sec. 892.1980  Radiologic table.

* * * * *
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.

    Dated: October 22, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-29189 Filed 11-2-98; 8:45 am]
BILLING CODE 4160-01-F