Document ID: FDA-2011-D-0476-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices
Posted Date: 2011-07-12T04:00Z

[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Notices]
[Pages 40921-40922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0476]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Enforcement Policy for Premarket Notification Requirements for 
Certain In Vitro Diagnostic and Radiology Devices; 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availability of the draft guidance entitled ``Enforcement Policy for 
Premarket Notification Requirements for Certain In Vitro Diagnostic and 
Radiology Devices.'' This document describes FDA's intent with regard 
to enforcement of premarket notification (510(k)) requirements for 
certain in vitro diagnostic and radiology devices under the 
regulations. This draft guidance is not final nor is it in effect at 
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 11, 2011.

[[Page 40922]]

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Enforcement Policy for Premarket 
Notification Requirements for Certain In Vitro Diagnostic and Radiology 
Devices'' to the Division of Small Manufacturers, International, and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5543, Silver Spring, MD 20993-0002, 301-
796-6217.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has identified certain Class I and Class II in vitro diagnostic 
and radiology devices that have established safety and effectiveness 
profiles and for which it believes 510(k) review is not necessary to 
assure safety and effectiveness. While FDA intends to exempt these 
devices from the 510(k) requirement through rulemaking that would 
reclassify the Class II devices and amend the classification 
regulations of the Class I devices, FDA no longer believes it is 
necessary to review premarket notification (510(k)) submissions for 
these devices before they enter the market. FDA is issuing a draft 
guidance concerning a policy of exercising enforcement discretion with 
regard to the 510(k) requirement for such devices. The draft guidance 
lists the devices for which, when the guidance is finalized, FDA 
intends to exercise enforcement discretion with regard to premarket 
notification requirements, subject to the limitations to the exemption 
criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 
892.9. FDA intends to continue to enforce all other applicable 
requirements under the FD&C Act, including, but not limited to: 
Registration and listing (21 CFR part 807); labeling (21 CFR part 801 
and 21 CFR 809.10); good manufacturing practice requirements as set 
forth in the Quality System regulation (21 CFR part 820); and Medical 
Device Reporting requirements (21 CFR part 803).

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 
``Enforcement Policy for Premarket Notification Requirements for 
Certain In Vitro Diagnostic and Radiology Devices.'' 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 draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Premarket Notification Enforcement Discretion for Certain In Vitro 
Diagnostic and Radiology Devices,'' 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 301-847-8149 to receive a hard copy. 
Please use the document number 1752 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. 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 part 807, subparts B and C 
have been approved under OMB control number 0910-0387; 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 801 and 
21 CFR 809.10 have been approved under OMB control number 0910-0485; 
and the collections of information in 21 CFR part 803 have been 
approved under OMB control number 0910-0437.

V. 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.

    Dated: July 6, 2011.
Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological 
Health.
[FR Doc. 2011-17352 Filed 7-11-11; 8:45 am]
BILLING CODE 4160-01-P