Document ID: FDA-2014-N-0237-0001
Agency: fda
Document Type: Notice
Title: Report to Congress; Report on the Food and Drug Administration’s Policy
To Be Proposed Regarding Premarket Notification Requirements for
Modifications to Legally Marketed Devices; Notice to Public of Web Site
Location of Report to Congress
Posted Date: 2014-03-06T05:00Z

[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Pages 12695-12696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04930]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0237]

Report to Congress; Report on the Food and Drug Administration's 
Policy To Be Proposed Regarding Premarket Notification Requirements for 
Modifications to Legally Marketed Devices; Notice to Public of Web Site 
Location of Report to Congress

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the Web site location where the Agency has posted the report 
entitled ``Report to Congress; Report on FDA's Policy to be Proposed 
Regarding Premarket Notification Requirements for Modifications to 
Legally Marketed Devices.'' In addition, FDA has established a docket 
where stakeholders may provide comments.

DATES: Submit either electronic or written comments by June 4, 2014.

ADDRESSES: Submit electronic comments on this document 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.

FOR FURTHER INFORMATION CONTACT: Mike Ryan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-6283.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
(Pub. L. 112-144) became law on July 9, 2012. FDASIA added section 
510(n)(2) to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 360(n)(2)). This new provision requires, no later than 18 
months after enactment of FDASIA, the Secretary of Health and Human 
Services to submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on when a premarket notification under 
section 510(k) of the FD&C Act (or a ``510(k)'') should be submitted 
for a modification to a legally marketed 510(k) device. This report 
fulfills that requirement.
    This notice announces the Web site location of ``Report to 
Congress; Report on FDA's Policy to be Proposed Regarding Premarket 
Notification Requirements for Modifications to Legally Marketed 
Devices.'' FDA invites interested persons to submit comments on this 
report. FDA has established a docket where comments may be submitted 
(see ADDRESSES). FDA believes this docket is an important tool for 
receiving information from interested parties and for sharing this 
information with the public. To access ``Report to Congress; Report on 
FDA's Policy to be Proposed Regarding Premarket Notification 
Requirements for Modifications to Legally Marketed Devices,'' visit 
FDA's Web site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm269873.htm.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received

[[Page 12696]]

comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at http://www.regulations.gov.

    Dated: February 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04930 Filed 3-5-14; 8:45 am]
BILLING CODE 4160-01-P