[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Notices]
[Page 58448-58449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0385]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Hepatitis A Serological
Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Hepatitis A Serological Assays for the Clinical
Laboratory Diagnosis of Hepatitis A Virus.'' This draft guidance
document describes a means by which in vitro diagnostic devices for the
laboratory diagnosis of Hepatitis A Virus may comply with the
requirement of special controls for class II devices. Elsewhere in this
issue of the Federal Register, FDA is publishing a proposed rule to
reclassify these device types from class III into class II (special
controls).
[[Page 58449]]
DATES: Submit written or electronic comments on this draft guidance by
December 29, 2004.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Hepatitis A Serological Assays for the
Clinical Laboratory Diagnosis of Hepatitis A Virus'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and
Radiological Health (HFZ- 440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2096.
SUPPLEMENTARY INFORMATION:
I. Background
This draft document was developed as a special control to support
the classification of in vitro diagnostic devices for the laboratory
diagnosis of Hepatitis A Virus (HAV) into class II (special controls).
Hepatitis A Virus Tests, Product Code LOL, are devices that detect
immunoglobulins M, (IgM), immunoglobulin G (IgG), and total antibodies
(IgM and IgG) reactive to HAV. The detection of HAV-specific antibodies
in human serum or plasma is laboratory evidence of HAV infection, with
the presence of IgM type antibodies differentiating an acute infection
from past infection.
This draft guidance document identifies the classification
regulation and product code for HAV-specific IgM, IgG, and total
antibody assays. In addition, other sections of this guidance document
list the risks to health identified by FDA and describe measures that,
if followed by manufacturers and combined with the general controls,
will generally address the risks associated with these assays and lead
to a timely premarket notification (510(k)) review and clearance. This
document supplements other FDA documents regarding the specific content
of a premarket notification submission.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on Class II
special controls for in vitro diagnostic devices for the laboratory
diagnosis of Hepatitis A Virus. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Hepatitis
A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis
A Virus'' by fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter
the system. At the second voice prompt, press 1 to order a document.
Enter the document number 1536 followed by the pound sign ().
Follow the remaining voice prompts to complete your request.
IV. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E, OMB No. 0910-0120). The labeling provisions addressed in the
guidance have been approved by OMB under OMB No. 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Comments received may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22010 Filed 9-29-04; 8:45 am]
BILLING CODE 4160-01-S