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510(k) Implementation: Discussion of an On-line Repository of Medical Device Labeling, and of Making Device Photographs Available in a Public Database Without Disclosing Propr...

Tue, 03/15/2011 - 4:37am
U.S. Food & Drug Administration

The meeting will be held on April 7th, 2011 from 8:30 a.m. to 5:00 p.m. and on April 8, 2011 from 8:30 a.m. to 12:00 p.m., at:

FDA White Oak Campus

10903 New Hampshire Ave

The Great Room (Room 1503), White Oak Conference Center

Silver Spring, MD, 20903

Submit written or electronic comments by May 10, 2011. Requests to make an oral presentation must be submitted by March 21, 2011.

Submit electronic comments 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.

Driving directions and parking information for the White Oak campus are available.

Food and drinks will be available for purchase by participants during the meeting breaks.

For information regarding logistics, registration and special accommodations, contact:

Susan Monahan

Office of Communication, Education, and Radiation Programs

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue, Bldg. 66

Silver Spring, MD 20993

phone: 301-796-5661

email: Susan.Monahan@fda.hhs.gov

For information regarding the program, contact:

Joyce Siwarski

Food and Drug Administration

10903 New Hampshire Ave.

Bldg. 66, rm. 5402

Silver Spring, MD 20903

Phone: 301-796-5422

FAX: 301-847-8510

e-mail: Joyce.Siwarski@fda.hhs.gov

    

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