[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Rules and Regulations]
[Pages 15828-15830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2005N-0471]


Microbiology Devices; Reclassification of Herpes Simplex Virus 
Types 1 and 2 Serological Assays

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying herpes 
simplex virus (HSV) types 1 and/or 2 (HSV 1 and 2) serological assays 
from class III (premarket approval) to class II (special controls). FDA 
had earlier proposed this reclassification on its own initiative based 
on new information. Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of a class II special controls 
guidance entitled ``Class II Special Controls Guidance Document: Herpes 
Simplex Virus Types 1 and 2 Serological Assays.''

DATES: This rule is effective May 3, 2007.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

A. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(SMDA) (Public Law 101-629), the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Public Law 105-115), and the Medical 
Device User Fee and Modernization Act (Public Law 107-250), established 
a comprehensive system for the regulation of medical devices intended 
for human use. Section 513 of the 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 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 act).
    Under section 513 of the 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. A person may market a 
preamendments device that has been classified into class III through 
premarket notification procedures, without submission of a premarket 
approval application (PMA), until FDA issues a final regulation under 
section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket 
approval.
    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 act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval unless and 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 act, as amended by FDAMA; or (3) issues an order 
finding the device to be substantially equivalent, under section 513(i) 
of the 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 a legally marketed device by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and 21 CFR part 807.
    Section 513(e) of the act governs reclassification of classified 
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 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 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 (D.C. 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). Whether data 
before the agency are past or new, the ``new information'' to support 
reclassification under section 513(e) of the act must be ``valid 
scientific evidence,'' as defined in section 513(a)(3) of the act and 
21 CFR

[[Page 15829]]

860.7(c)(2) (see, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. 
Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. 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. To be 
considered in the reclassification process, 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 act (21 U.S.C. 360j(c)).
    FDAMA added section 510(m) to the act that provides that a class II 
device may be exempted from the premarket notification requirements 
under section 510(k) of the act if the agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device.

B. Regulatory History of the Device

    In the Federal Register of January 9, 2006 (71 FR 1399), FDA 
published a proposed 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 draft guidance document entitled ``Class II Special Controls 
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological 
Assays'' as the special control. Interested persons were invited to 
comment on the proposed rule by April 10, 2006 (the draft guidance was 
announced in the Federal Register of January 9, 2006 (71 FR 1432). A 
proposed rule correcting the reference section of the January 9, 2006, 
proposed rule was published on March 13, 2006 (71 FR 12653). FDA 
received no comments on the proposed reclassification.

II. FDA's Conclusions

    Based on the information discussed in the preamble to the proposed 
rule (71 FR 1399), FDA concludes that special controls, in conjunction 
with general controls, provide reasonable assurance of the safety and 
effectiveness of these devices. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of the special controls 
guidance document. Following the effective date of this final 
classification rule, any firm submitting a 510(k) premarket 
notification for a HSV 1 and 2 serological assay will need to address 
the issues covered in the special control 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.
    FDA is now codifying the classification and the special control 
guidance document for HSV 1 and 2 serological assays by amending Sec.  
866.3305 (21 CFR 866.3305). As stated in the proposed rule, FDA 
considered HSV 1 and 2 serological assays in accordance with section 
510(m) of the act and determined that the device does need premarket 
notification to assure the safety and effectiveness of HSV 1 and 2 
serological assays.
    As stated in the preamble to the proposed rule (71 FR 1399), HSV 
serological assays of types other than type 1 and 2 will remain in 
class III. HSV nucleic acid amplification assays are not within the 
device type classified in Sec.  866.3305.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, and the Regulatory Flexibility Act (Public Law 96-354) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
(Public Law 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 and 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.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Reclassification of HSV 1 and 2 serological assays 
from class III to class II will relieve manufacturers of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. Furthermore, the special controls guidance document does not 
impose any new burdens on manufacturers; it advises manufacturers about 
ways to comply with the special controls that allow the agency to down 
classify these devices. By eliminating the need for premarket approval 
applications, reclassification will reduce regulatory costs with 
respect to these devices, impose no significant economic impact on any 
small entities, and may permit small potential competitors to enter the 
marketplace by lowering their costs. The agency therefore certifies 
that this 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 $122 million, using the most current (2005) 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.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 866

    Medical devices.


0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 15830]]

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 revised to read as follows:


Sec.  866.3305  Herpes simplex virus serological assays.

    (a) Identification. Herpes simplex virus serological assays are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to herpes simplex virus in 
serum. Additionally, some of the assays 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. The 
identification aids in the diagnosis of diseases caused by herpes 
simplex viruses and provides epidemiological information on these 
diseases. Herpes simplex viral infections range from common and mild 
lesions of the skin and mucous membranes to a severe form of 
encephalitis (inflammation of the brain). Neonatal herpes virus 
infections range from a mild infection to a severe generalized disease 
with a fatal outcome.
    (b) Classification. (1) Class II (special controls). The device is 
classified as class II (special controls) if the herpes simplex virus 
serological assay is type 1 and/or 2. The special control for the 
device is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological 
Assays.'' For availability of the guidance document, see Sec.  
866.1(e).
    (2) Class III (premarket approval). The device is classified as 
class III if the herpes simplex virus serological assay is a type other 
than type 1 and/or 2.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established for the requirement for premarket 
approval for the devices described in paragraph (b)(2) of this section. 
See Sec.  866.3.

    Dated: March 23, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-6167 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S