Document ID: FDA-2011-D-0453-0026
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Availability; Reopening of Comment Period
Posted Date: 2011-11-08T05:00Z

[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Page 69274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28875]

[[Page 69274]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0453]

Draft Guidance for Industry and Food and Drug Administration 
Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) 
for a Change to an Existing Device; Availability; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
November 28, 2011, the comment period for the notice entitled ``Draft 
Guidance for Industry and Food and Drug Administration Staff; 510(k) 
Device Modifications: Deciding When to Submit a 510(k) for a Change to 
an Existing Device; Availability,'' that appeared in the Federal 
Register of July 27, 2011 (76 FR 44935). In that document, FDA 
announced the availability of a draft guidance for industry and FDA 
staff and requested comments. The Agency is taking this action to allow 
interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by November 28, 
2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT:

Michael J. 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; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, (301) 827-6210.

I. Background

    In the Federal Register of July 27, 2011 (76 FR 44935), FDA 
published a notice with a 90-day comment period to request comments on 
the draft guidance for industry and FDA staff entitled ``510(k) Device 
Modifications: Deciding When to Submit a 510(k) for a Change to an 
Existing Device.'' Comments on the draft guidance will assist FDA in 
the development of a final guidance for industry and FDA staff.
    FDA is reopening the comment period for the notice until November 
28, 2011. The Agency believes that this will allow adequate time for 
interested persons to submit comments without significantly delaying 
action by the Agency.

II. 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.

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 Center for 
Devices and Radiological Health (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 or from the Center for Biologics Evaluation 
and Research at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``510(k) Device Modifications: Deciding When to Submit a 510(k) for a 
Change to an Existing Device'' from CDRH, 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 1793 to identify the guidance you 
are requesting.

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28875 Filed 11-7-11; 8:45 am]
BILLING CODE 4160-01-P