Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, September 4, 2012

Register by September 5: FDA Medical Device UDI webinar

The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Strengthening the National Medical Device Postmarket Surveillance System.” The purpose of this meeting is to solicit public feedback regarding FDA’s proposal to strengthen the national medical device postmarket surveillance system.
                Date, Time and Location 
                Federal Register Notice
                Contact Us
Date, Time and Location
This meeting will be held September 10, 2012, beginning at 9:00 a.m. - 4:00 p.m. at the following location:
Greenbelt Marriott
6400 Ivy Lane,
Greenbelt, MD 20770
The meeting will be available by Webcast.
Available soon.
Registration to Attend the Meeting
If you wish to attend this meeting in person, you must register online by September 10, 2012. If you wish to view this meeting by Webcast, you must register by close of business on September 5, 2012.
There is no fee to register for the meeting 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 during an open comment session at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and 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 discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Joyce Raines, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO-66 Room 4319, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, email:, no later than September 5, 2012.
Contact Us
For questions regarding workshop content please contact:
Anita Rayner 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Avenue, WO-66 Room 3316 
Silver Spring, MD 20993 
Danica Marinac-Dabic
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Avenue, WO-66 Room 4110 
Silver Spring, MD 20993
301 - 796-6689
Page Last Updated: 09/04/2012 

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