[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Rules and Regulations]
[Pages 48715-48717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20115]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2010-N-0429]
Immunology and Microbiology Devices; Reclassification of the
Herpes Simplex Virus Serological Assay Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the special
controls for the herpes simplex virus (HSV) serological assay device
type, which is classified as class II (special controls). These device
types are devices that consist of antigens and antisera used in various
serological tests to identify antibodies to herpes simplex virus in
serum, and the devices that consist of herpes simplex virus antisera
conjugated with a fluorescent dye (immunofluorescent assays) used to
identify herpes simplex virus directly from clinical specimens or
tissue culture isolates derived from clinical specimens.
DATES: This rule is effective September 8, 2011.
FOR FURTHER INFORMATION CONTACT: Haja Sittana El Mubarak, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg 66, Rm. 5519, Silver Spring, MD 20993-0002,
301-796-6193.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), Safe Medical Devices Act (SMDA)
(Pub. L. 101-629), Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115), and the Medical Device User Fee and
Modernization Act (MDUFMA) (Pub. L. 107-250), 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, defined by the regulatory
controls needed to provide reasonable assurance of their safety and
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, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as preamendments devices. FDA classifies these
devices after it takes the following steps: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
Devices that were not in commercial distribution before May 28,
1976, generally referred to as postamendments devices are classified
automatically by statute (section 513(f) of the FD&C Act) into class
III without any FDA rulemaking process. Those devices remain in class
III until FDA does the following: (1) Reclassifies the device into
class I or II; (2) issues an order classifying the device into class I
or II in accordance with section 513(f)(2) of the FD&C Act; or (3)
issues an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a legally marketed
device that has been classified into class I or class II. The agency
determines whether new devices are substantially equivalent to
previously marketed devices by means of premarket notification
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21
CFR part 807 of the regulations.
Under the 1976 amendments, class II devices were defined as devices
for which there was insufficient information to show that general
controls themselves would provide reasonable assurance of safety and
effectiveness, but for which there was sufficient information to
establish performance standards to provide such assurance. SMDA
broadened the definition of class II devices to mean those devices for
which the general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there
is sufficient information to establish special controls to provide such
assurance, including performance standards, postmarket surveillance,
patient registries, development and dissemination of guidelines,
recommendations, and any other appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the FD&C Act).
Elsewhere in this issue of the Federal Register, FDA is announcing
the
[[Page 48716]]
availability of the revised guidance document entitled ``Class II
Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2
Serological Assays'' that will serve as the special control for the
device. Because FDA is amending the special control for this device
type, the agency is publishing the final rule that designates the
revised guidance document as the special control for HSV serological
devices.
II. Regulatory Background of the Device
As a preamendments device, HSV 1 and 2 serological assays were
classified into class III in a final rule in the Federal Register of
November 9, 1982 (47 FR 50823) following the receipt of a
classification recommendation from a classification panel and the
issuance of a proposed rule as required by section 513(b) of the FD&C
Act. In the Federal Register of April 3, 2007 (72 FR 15829), FDA
published a final rule to reclassify HSV 1 and 2 serological assays
into class II. These assays are used as an aid in the clinical
laboratory diagnosis of diseases caused by HSV 1 and 2. FDA identified
the guidance document entitled ``Class II Special Controls Guidance
Document: Herpes Simplex Virus Types 1 and 2 Serological Assays'' as
the special control. Since April 3, 2007, FDA believed it had become
aware of sufficient additional safety and efficacy profile information
to justify revision of the special controls to better provide assurance
of the safety and effectiveness of the device. Accordingly, in the
Federal Register of September 28, 2010 (75 FR 59670), FDA issued a
proposed rule to amend the special controls guidance for the device and
replace it with a new guidance of the same name. FDA invited interested
persons to comment on the proposed rule by November 29, 2010. No
comments germane to this rule were received by the agency.
III. Summary of the Reasons for Revising Special Controls
The final rule revises the special controls for HSV 1 and 2
serological assays because the new special controls, in addition to
general controls, provide reasonable assurance of the safety and
effectiveness of the device. FDA believes there is sufficient
additional safety and efficacy profile information to justify this
revision of the special controls to better provide such assurance. We
revised the existing guidance by rewriting the method comparison
section and the sample selection inclusion and exclusion criteria
section. The revisions defined and differentiated the required studies
and the study populations for the assessment of the safety and
effectiveness of the different types of HSV1 and HSV2 serological
assays. Additionally, we made several corrections and clarifications
throughout the document to ensure accuracy, consistency, and ease of
reading.
IV. Special Controls
In addition to general controls, FDA believes that the revised
guidance document entitled ``Class II Special Controls Guidance
Document: Herpes Simplex Virus Types 1 and 2 Serological Assays'' (the
class II special controls guidance document) is a special control that
is adequate to address the risks to health associated with the use of
the device. FDA believes that the revised class II special controls
guidance document, which incorporates voluntary consensus standards and
describes labeling recommendations, in addition to general controls,
provides reasonable assurance of the safety and effectiveness of the
device.
Following the effective date of this final rule, any firm
submitting a 510(k) for HSV 1 and 2 serological assays 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.
V. FDA's Findings
As discussed previously in this document, FDA believes HSV 1 and 2
serological assays should be classified into class II because special
controls, in addition to general controls, provide reasonable assurance
of the safety and effectiveness of the device and because there is
sufficient information to establish special controls to provide such
assurance. FDA, therefore, is finalizing the establishment of the
revised class II special controls guidance document as a special
control for the device.
Section 510(m) of the FD&C Act provides that a class II device may
be exempt from the premarket notification requirements under section
510(k) of the FD&C Act, if the agency determines that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. For this device, FDA believes
that premarket notification is necessary to provide reasonable
assurance of safety and effectiveness and, therefore, is not exempting
the device from the premarket notification requirements.
VI. 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 nor an environmental impact statement is required.
VII. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct 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 Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the changes to the guidance are minimal, 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 $136 million, using the most current (2010) 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.
The changes to the guidance include adding specific recommendations
on appropriate comparators for tests for antibodies and antigens, as
well as recommendations for sample selection inclusion and exclusion
criteria to define the target populations for HSV 1 and HSV 2
serological assays. These recommended changes increase the usefulness
of the guidance while imposing a minimal burden.
[[Page 48717]]
VIII. 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
authority 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. 21
U.S.C. 360k; See Medtronic Inc., v. Lohr 518 U.S. 470 (1996); Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008). The special controls established
by this final rule create ``requirements'' for specific medical devices
under 21 U.S.C. 360k, even though products sponsors have some
flexibility in how they meet those requirements. Cf. Papike v.
Tambrands, Inc., 107 F. 3d 737, 740-742 (9th Cir. 1991).
IX. Paperwork Reduction Act of 1995
This final rule contains no new 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. This final rule establishes as special controls a guidance
document that refers to currently approved collections of information
found in other FDA regulations. These collections of information are
subject to review by OMB under the PRA. The analysis of the paperwork
burden for the guidance document is included in its notice of
availability.
List of Subjects in 21 CFR Part 866
Biologics, Laboratory, 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
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for 21 CFR part 866 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 866.3305 is amended by revising paragraph (b) to read as
follows:
Sec. 866.3305 Herpes simplex virus serological assays.
* * * * *
(b) Classification. Class II (special controls). The device is
classified as class II (special controls). The special control for the
device is FDA's revised guidance document entitled ``Class II Special
Controls Guidance Document: Herpes Simplex Virus Types 1 and 2
Serological Assays.'' For availability of the guidance revised
document, see Sec. 866.1(e).
Dated: August 3, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20115 Filed 8-8-11; 8:45 am]
BILLING CODE 4160-01-P