[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