[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Rules and Regulations]
[Pages 22805-22807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2006-N-0045] (Formerly Docket No. 2006N-0109)


Medical Devices; Reclassification of the Topical Oxygen Chamber 
for Extremities

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the 
topical oxygen chamber for extremities (TOCE) from class III to class 
II. This device is intended to surround a patient's limb and apply 
humidified oxygen topically at a pressure slightly greater than 
atmospheric pressure to aid healing of chronic skin ulcers, such as 
bedsores. This reclassification is on the Secretary of Health and Human 
Services's own initiative based on new information. This action is 
being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) as amended by the Medical Device Amendments of 1976 (the 1976 
Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the 
Food and Drug Administration Modernization Act of 1997 (FDAMA). 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' 
which will serve as the special control for this device.

DATES: This rule is effective May 25, 2011.

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3555.

SUPPLEMENTARY INFORMATION:

I. Background

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the 1976 
Amendments (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and the FDAMA 
(Pub. L. 105-115), established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of 
devices, depending on the regulatory controls needed to provide 
reasonable assurance of their safety and

[[Page 22806]]

effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
Amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the FD&C Act (21 U.S.C. 
360c(f)) into class III without any FDA rulemaking process. 
Postamendment devices remain in class III and require premarket 
approval, unless the device is reclassified into class I or II, or FDA 
issues an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to 
a predicate device that does not require premarket approval. The agency 
determines whether new devices are substantially equivalent to 
predicate devices by means of premarket notification procedures in 
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the 
regulations (21 CFR part 807).
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the FD&C Act (21 U.S.C. 
360e(b)) requiring premarket approval.
    Section 513(e) of the FD&C Act (21 U.S.C. 360c(e)) governs 
reclassification of classified preamendments devices. This section 
provides that FDA may, by rulemaking, reclassify a device based upon 
``new information.'' FDA can initiate a reclassification under section 
513(e) of the FD&C Act or an interested person may petition FDA to 
reclassify a preamendments device. The term ``new information,'' as 
used in section 513(e) of the FD&C Act, includes information developed 
as a result of a reevaluation of the data before the agency when the 
device was originally classified, as well as information not presented, 
not available, or not developed at that time. (See, e.g., Holland 
Rantos v. United States Department of Health, Education, and Welfare, 
587 F.2d 1173, 1174 n.1 (DC Cir. 1978); Upjohn v. Finch, 422 F.2d 944 
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966)).
    Reevaluation of the data previously before the agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F. Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in 
``medical science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951). 
Regardless of whether data before the agency are past or new data, the 
``new information'' to support reclassification under section 513(e)(1) 
of the FD&C Act must be ``valid scientific evidence,'' as defined in 
section 513(a)(3) of the FD&C Act (21 U.S.C. 360c(a)(3)) and 21 CFR 
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (DC 
Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (DC Cir.), cert. 
denied, 474 U.S. 1062 (1985)). FDA relies upon ``valid scientific 
evidence'' in the classification process to determine the level of 
regulation for devices. For the purpose of reclassification, the valid 
scientific evidence upon which the agency relies must be publicly 
available. Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).
    In accordance with section 513(e) of the FD&C Act and 21 CFR 
860.130(b)(1), based on new information with respect to the device, 
FDA, on its own initiative, is reclassifying this device from class III 
to class II.

II. Regulatory History of the Device

    As discussed in the proposed rule, the agency issued a final rule 
classifying this device into class III (53 FR 23856, June 24, 1988). In 
August 1997, in response to FDA's order for the submission of 
information on the TOCE, two manufacturers submitted 515(i) summaries 
of safety and effectiveness information to the agency for the TOCE. FDA 
referred the 515(i) submissions to the General and Plastic Surgery 
Devices Panel (GPS Panel) for their recommendation on the requested 
reclassification. At a public meeting on November 17, 1998, the GPS 
Panel recommended that the device be retained in class III.
    Since the 1998 GPS Panel meeting, three studies (two prospective 
and one retrospective) reported safe use and adequate healing of wounds 
using the TOCE. In addition, FDA has evaluated more than 20 years of 
clinical experience with the device and the agency's Medical Device 
Reports, and has found sufficient information to determine the risks to 
health associated with the use of this device and develop appropriate 
special controls.
    As a result, in the Federal Register of April 6, 2006 (71 FR 
17390), FDA proposed to reclassify the TOCE device from class III to 
class II. The device is intended to surround a patient's limb and apply 
humidified oxygen topically at a pressure slightly greater than 
atmospheric pressure to aid healing of chronic skin ulcers such as 
bedsores. Elsewhere in the Federal Register of April 6, 2006 (71 FR 
17476), FDA announced the availability of the draft guidance document 
entitled ``Class II Special Controls Draft Guidance Document: Topical 
Oxygen Chamber for Extremities,'' which FDA intended to serve as the 
special control for this device type following the effective date of 
the final reclassification rule.
    Interested persons were invited to comment until July 5, 2006, on 
the proposed regulation and special controls draft guidance document.

III. Analysis of Comments and FDA's Response

    FDA received 11 comments on the proposed rule. The comments 
received discussed academic literature, clinical experiences, and 
patient outcomes that support the proposed reclassification's 
determinations of the safety and effectiveness of the TOCE device. The 
comments did not recommend any changes to the proposed regulation.

IV. Summary of Final Rule

    Based on the information discussed in the preamble to the proposed 
rule, the comments on the proposed rule, a review of the Manufacturer 
and User Facility Device Experience (MAUDE) database, and a review of 
current scientific literature, FDA concludes that special controls, in 
conjunction with general controls, will provide reasonable assurance of 
the safety and effectiveness of TOCE. The agency is, therefore, 
reclassifying TOCE from class III (premarket approval) into class II 
(special controls) and issuing a final rule that revises 21 CFR 
878.5650. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of the guidance document entitled ``Class 
II Special Controls Guidance Document: Topical Oxygen Chamber for 
Extremities,'' which will serve as the special control for this device. 
Following the effective date of this final classification rule, any 
firm

[[Page 22807]]

submitting a 510(k) premarket notification for a TOCE will need to 
address the issues covered in the special controls guidance. However, 
the firm need only show that its device meets the recommendations of 
the guidance or in some other way provides equivalent assurances of 
safety and effectiveness.
    Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that FDA 
may exempt a class II device from the premarket notification 
requirements under section 510(k) of the FD&C Act if FDA determines 
that premarket notification is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the TOCE and, 
therefore, this device type is not exempt from premarket notification 
requirements.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
reclassification action is of a type that does not individually or 
cumulatively have a significant effect on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

VI. 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 
the Unfunded Mandates Reform Act of 1995 (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 not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the final rule reclassifying this device 
from class III to class II will relieve all manufacturers of the device 
of the cost of complying with the premarket approval requirements of 
section 515 of the FD&C Act, it will impose no significant economic 
impact on any small entities, and it may permit small potential 
competitors to enter the marketplace by lowering their costs, and the 
agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State law 
conflicts with the exercise of Federal authority under the Federal 
statute.'' Federal law includes an express preemption provision that 
preempts certain State requirements ``different from or in addition 
to'' certain Federal requirements applicable to devices. (See section 
521 of the FD&C Act (21 U.S.C. 360k); Medtronic Inc., v. Lohr, 518 U.S. 
470 (1996); Riegel v. Medtronic Inc., 128 S. Ct. 999 (2008)). The 
special controls established by this final rule create ``requirements'' 
for specific medical devices under 21 U.S.C. 360k, even though product 
sponsors have some flexibility in how they meet those requirements. See 
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997).

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not 
required. FDA concludes that the special controls guidance document 
identified by this rule contains information collection provisions that 
are subject to review and clearance by OMB under the PRA.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice announcing the availability of the guidance document entitled, 
``Class II Special Controls Guidance Document: Topical Oxygen Chamber 
for Extremities.'' The notice contains an analysis of the paperwork 
burden for the guidance.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:


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


0
2. Section 878.5650 is revised to read as follows:


Sec.  878.5650  Topical oxygen chamber for extremities.

    (a) Identification. A topical oxygen chamber for extremities is a 
device that is intended to surround a patient's limb and apply 
humidified oxygen topically at a pressure slightly greater than 
atmospheric pressure to aid healing of chronic skin ulcers such as 
bedsores.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance: 
Topical Oxygen Chamber for Extremities.'' See Sec.  878.1(e) for the 
availability of this guidance document.

    Dated: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9899 Filed 4-22-11; 8:45 am]
BILLING CODE 4160-01-P