[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Proposed Rules]
[Pages 59670-59672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23639]
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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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
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.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the revised draft guidance document entitled ``Class II
Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2
Serological Assays'' that would serve as the special control for the
device, if FDA amends the special controls. Because FDA is proposing to
amend the special control for this device type, the agency is
publishing the proposed rule that designates the revised guidance
document as the special control for HSV serological devices.
DATES: Submit written or electronic comments on the proposed rule by
November 29, 2010.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0429, by any of the following methods, except that comments on
information collection issues under the Paperwork Reduction Act of 1995
must be submitted to the Office of Regulatory Affairs, Office of
Management and Budget (OMB) (see the ``Paperwork Reduction Act of
1995'' section of this document).
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by email. FDA encourages you
to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Haja Sittana El Mubarak, Center for
Devices and Radiological Health, Bldg. 66, rm. 5519, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-6193.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
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), Safe
Medical Devices Act (SMDA) (Public Law 101-629), Food and Drug
Administration Modernization Act (FDAMA) (Public Law 105-115), and the
Medical Device User Fee and Modernization Act (MDUFMA) (Public Law 107-
250), established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c) established three
categories (classes) of devices, defined
[[Page 59671]]
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).
II. Regulatory Background of the Device
In the Federal Register of April 3, 2007 (72 FR 15830), 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.
III. Summary of the Reasons for Revising Special Controls
FDA believes that the special controls for HSV 1 and 2 serological
assays should be revised because the new special controls, in addition
to general controls, would provide reasonable assurance of the safety
and effectiveness of the device. FDA believes there is sufficient
additional safety and efficacy profile information to justify revising
the special controls to better provide such assurance. We have 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 HSV 1 and HSV 2 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
draft 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. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice of availability of the revised draft class II
special controls guidance document that the Agency would use as the
special control for this device.
The revised draft class II special controls guidance document sets
forth the information FDA believes should be included in premarket
notification submissions (510(k)s) for HSV 1 and 2 serological assays.
FDA believes that addressing these risks to health in a 510(k) in the
manner identified in the revised class II special controls guidance
document, or in an acceptable alternative manner, is necessary to
provide reasonable assurance of the safety and effectiveness of the
device.
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 proposing to establish the revised draft
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, does not intend
to exempt the device from the premarket notification requirements.
VI. Effective Date
FDA proposes that any final regulation based on this proposal
become effective 30 days after its date of publication in the Federal
Register.
VII. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
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.
VIII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public
[[Page 59672]]
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 proposed rule is not a significant
regulatory action as defined by 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 changes to the guidance are minimal, the
Agency proposes to certify 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
proposed 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 would increase the
usefulness of the guidance while imposing a minimal burden.
IX. Federalism
FDA has analyzed this proposed 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.
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr
518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)).
If this proposed rule is made final, the special controls established
by the final rule would 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)).
X. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no new
collections of information. Therefore, clearance by OMB under the
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) is not
required.
This proposed rule designates a revised guidance document as a
special control. FDA also tentatively concludes that the revised draft
special control guidance document does not contain new 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 that revised draft
guidance document entitled ``Class II Special Controls Guidance
Document: Herpes Simplex Virus Types 1 and 2 Serological Assays,''
which contains an analysis of the paperwork burden for the draft
guidance.
XI. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 866
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 866 be amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
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.
2. Revise Sec. 866.3305 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. 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 revised guidance
document, see Sec. 866.1(e).
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23639 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S