Friday, April 24, 2009

FDA Office of Device Evaluation Holds Internal Meeting

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The Food and Drug Administration held a rare all staff meeting on Wednesday within the Office of Device Evaluation. The NY Times cited an internal email memorandum sent by Dr. Donna-Bea Tillman, the Deputy Director for Clinical Affairs within the Office of Device Evaluation, calling for a meeting to discuss the "strategic direction of the device center." It is unclear exactly what was discussed or came from this meeting.

The FDA has recently come under fire yet again, with agency officials being accused by their colleagues and reviewers of acting illegally and potentially jeopardizing patient safety. This is in addition to the criticism we reported on by the Government Accountability Office with regards to the Class III medical device approval process.

It is unclear how all of these recent events will affect the future of medical device approval process.

NY Times : Rare F.D.A. Meeting to Discuss Complaints on Device Approval...

FDA : Office of Device Evaluation

Flashback : FDA Scrutinizing "New" Medical Devices...

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