Federal Register: September 30, 2004 (Volume 69, Number 189)
DOCID: FR Doc 04-22010
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. 2004D-0385]
ACTION: Reports and guidance documents; availability, etc.:
DOCUMENT ACTION: Notice.
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
DATES: Submit written or electronic comments on this draft guidance by December 29, 2004.
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availability of the draft guidance entitled ``Class II Special Controls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 This draft guidance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).
Medical devices—; Hepatitis A serological assays for clinical laboratory diagnosis of hepatitis A virus; Class II special controls,
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 HAVspecific 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This draft guidance document identifies the classification regulation and product code for HAVspecific IgM, IgG, and total antibody assays.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 FactsOnDemand system at 800
8990381 or 3018270111 from a touchtone 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 (
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 35013520) (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. 09100120). The labeling provisions addressed in the guidance have been approved by OMB under OMB No. 09100485.
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. 0422010 Filed 92904; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Sally Hojvat, Center for Devices and Radiological Health (HFZ 440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 3015942096.