[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