Notice: Guidance for Industry and Food and Drug Administration Staff; 
Enforcement Policy for Premarket Notification Requirements for Certain 
In Vitro Diagnostic and Radiology Devices; Availability

Federal Register: Volume 76, Number 244 (Tuesday, December 20, 2011)
                  Pages 78930-78931

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the 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.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the 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 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 guidance 
concerning a policy of exercising enforcement discretion with regard to 
the 510(k) requirement for such devices. The guidance lists the devices 
for which 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 (part 807 (21 CFR part 807)); labeling 
(part 801 (21 CFR part 801) and Sec.  809.10 (21 CFR 809.10)); good 
manufacturing practice requirements as set forth in the Quality System 
regulation (part 820 (21 CFR part 820)); and Medical Device Reporting 
requirements (part 803 (21

[[Page 78931]]

CFR part 803)). The draft guidance published in the Federal Register on 
July 12, 2011 (76 FR 40921), and the comment period closed on October 
11, 2011. There were 5 comments received.

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 ``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 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 
``Enforcement Policy for Premarket Notification Requirements for 
Certain In Vitro Diagnostic and Radiology Devices,'' you may either 
send an email 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 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 part 807, 
subpart E have been approved under OMB control number 0910-0120; the 
collections of information in part 807, subparts B and C have been 
approved under OMB control number 0910-0387; the collections of 
information in part 820 have been approved under OMB control number 
0910-0073; the collections of information in part 801 and Sec.  809.10 
have been approved under OMB control number 0910-0485; and the 
collections of information in 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: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32437 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P