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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting - Recommendations Proposed in Institute of Medicine Report: "Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years," September 16, 2011

The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Recommendations Proposed in Institute of Medicine Report: ‘Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.’”

The purpose of the meeting is to encourage public comment on the recommendations proposed in the Institute of Medicine (IOM) report.


Date, Time and Location

This meeting will be held on September 16, 2011, beginning at 8:30 a.m., at the following location:

Silver Spring Hilton Hotel
8727 Colesville Road  
Silver Spring , Maryland, 20910

The meeting will not be videotaped or webcasted.

Agenda

TimeEventSpeaker
7:30 – 8:30Registration 
8:30 – 8:35Welcome – Opening RemarksMs. Marjorie Shulman,
Acting Director,
Premarket Notification
(510(k)) Program,
CDRH/FDA
8:35 – 8:45IntroductionDr. Jeff Shuren, Director,
CDRH/FDA
8:45 – 9:05Overview of IOM’s RecommendationsDr. David Challoner,
Chair of the IOM Committee
9:05 – 11:30Public Presentations and Comments 
11:30 – 12:30LUNCH  
12:30 – 2:00Public Presentations and Comments 
2:00 – 2:30Additional Presentations and Comments 
2:30 – 3:00Closing Remarks/Adjourn 

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by 5:00 p.m. on September 15, 2011

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation at the meeting, you must indicate this at the time of registration. FDA requests that presentations focus on the recommendations identified in section II of the FR notice. You should also identify which recommendation you wish to address in your presentation. You must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the recommendation at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

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Contact Us

For information regarding the program, contact:

Philip Desjardins
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, rm. 5452
Silver Spring, MD 20993
Phone: 301-796-5678
Email: philip.desjardins@fda.hhs.gov