[Federal Register Volume 72, Number 178 (Friday, September 14, 2007)]
[Notices]
[Pages 52568-52570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0336]
Guidance for Industry and Food and Drug Administration Staff;
Commercially Distributed Analyte Specific Reagents: Frequently Asked
Questions; 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 guidance entitled ``Commercially Distributed
Analyte Specific Reagents (ASRs): Frequently Asked Questions.'' FDA is
issuing this guidance to clarify the regulations regarding commercially
distributed ASRs and the role and responsibilities of ASR
manufacturers. The draft of this guidance was issued September 7, 2006.
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
Manufacturers should ensure their Class II or Class III in vitro
diagnostic devices, that are currently inappropriately labeled and
marketed as ASRs, comply with the law by September 15, 2008.
ADDRESSES: Submit written requests for single copies of the guidance
document
[[Page 52569]]
entitled ``Commercially Distributed Analyte Specific Reagents (ASRs):
Frequently Asked Questions'' 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 or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive
label to assist the office in processing your request, or fax your
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this 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 either http://www.fda.gov/dockets/ecomments or http://
www.regulations.gov. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Courtney Harper, Center for Devices and Radiological Health (HFZ-
440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD
20850, 240-276-0694.
For further information concerning the guidance as it related to
devices regulated by CBER: Martin Ruta, Center for Biologics Evaluation
and Research (HFM-300), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-827-3518.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is providing this guidance in order to minimize confusion
regarding particular marketing practices pertaining to ASRs. The
guidance is not intended to cover the role of clinical laboratories in
the development of laboratory developed tests. As noted in this
guidance document, ASRs are building blocks of laboratory developed
tests. With this final guidance document, FDA seeks to advise ASR
manufacturers that it views certain practices as being inconsistent
with the marketing of an ASR, as defined under Sec. 864.4020 (21 CFR
864.4020). Some manufacturers have believed that when they combine a
Class I ASR, which is exempt from premarket notification requirements
under section 510(l) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(l)), with other products, or with instructions for use in a
specific test, the product may still be regarded as an ASR that retains
class I exempt status because the product contains an ASR. However, as
explained in this guidance, when an ASR is marketed in combination with
other products, with instructions for use, or with specific claims, FDA
views the product as no longer being an ASR within the meaning of Sec.
864.4020. Instead, FDA views products marketed in this way as another
type of in vitro diagnostic device (IVD) or device component not
covered by the ASR regulations and, therefore, not necessarily exempt
from premarket notification.
The draft of this guidance was published in the Federal Register of
September 7, 2006 (71 FR 52799). FDA received and considered more than
30 sets of comments on the draft guidance document. After taking the
comments into consideration, FDA has revised the draft document to
provide clarifications as needed. This includes clarifying that FDA
views ASRs as being intended to detect a single ligand or target. This
guidance further clarifies that oligonucleotide primer pairs and
polyclonal antibodies can meet the definition of an ASR when properly
marketed because they are for the identification of a single target or
ligand (e.g., used to detect a single protein, a single nucleotide
change, a single epitope). In addition, FDA has clarified that where
manufacturers provide laboratories with information describing the use
of their product in a specific test, the manufacturer's product would
fall outside the definition of an ASR.
In order to assist manufacturers of Class II or III IVDs that are
currently being inappropriately labeled and marketed as ASRs to come
into regulatory compliance, FDA intends to exercise enforcement
discretion with respect to premarket approval and clearance
requirements for 12 months (see DATES). Manufacturers should ensure
their products comply with the law by (see DATES).
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on commercially distributed ASRs. 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
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Commercially Distributed Analyte
Specific Reagents (ASRs): Frequently Asked Questions,'' you may either
send an e-mail request to dsmica@fda.hhs.gov to receive an electronic
copy of the document or send a fax request to 240-276-3151 to receive a
hard copy. Please use the document number 1590 to identify the guidance
you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the CBER Internet site at http://www.fda.gov/cber/
guidelines.htm or on the Division of Dockets Management Internet site
at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR 809.10 and 809.30 (Sec. 809.30) have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 803
have been approved under OMB control number 0910-0437; the collections
of information in 21 CFR 807.22 and 807.31(e) are approved under OMB
control number 0910-0387; the collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR
[[Page 52570]]
814.20 have been approved under OMB control number 0910-0231.
In addition, the labeling for Class I, exempt ASRs must bear the
statement, ``Analyte Specific Reagent. Analytical and performance
characteristics are not established.'' Class II or III ASRs must bear
the statement, ``Analyte Specific Reagent. Except as a component of the
approved/cleared test (name of approved/cleared test), analytical and
performance characteristics are not established'' (Sec. 809.30(d)(2)
and (d)(3)). The disclaimer and these statements do not constitute
``collections of information'' under the PRA. Rather, they are ``public
disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
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 paper copy.
Comments are to be identified 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.
Dated: September 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18108 Filed 9-13-07; 8:45 am]
BILLING CODE 4160-01-S