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, April 7, 2015

Sign up & speak up! FDA April 21: Patient outcomes and risk of medical devices

Public Workshop - An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment - April 21, 2015

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Clinical Considerations of Risk in the Postmarket Environment."
The purpose of the workshop is to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator, or member of the public actually uses the device.

Date, Time and Location:
This meeting will be held April 21, 2015, beginning at 8:30 a.m. (EDT) to 5:00 p.m. (EDT) at the following location:
FDA White Oak Campus 
10903 New Hampshire Avenue 
Bldg. 31, Room 1503 (the Great Room) 
Silver Spring, MD, 20993
The meeting will be webcast.
The agenda will be posted soon.
Registration to Attend the Workshop:
If you wish to attend this Workshop, you must register by 4:00 pm on April 13, 2015


First Name *

Last Name *

Phone Number*

Company or Organization *

Request to Speak *
 Yes No
Topic you wish to address:

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 a comment during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that comments 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 Susan Monahan, Office of Communications and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661,
For questions regarding workshop content please contact: Jean M. Cooper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5540, Silver Spring MD 20993, 301-796-6141, email:

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