FDA whistleblowing regarding unsafe medical devices

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

FDA whistleblowing regarding unsafe medical devices

PostPosted by Erica » Mon Jan 30, 2012 1:45 pm

“It always seems impossible until it's done.” Nelson Mandela
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Re: FDA whistleblowing regarding unsafe medical devices

PostPosted by hopeful19 » Mon Jan 30, 2012 2:20 pm

Amazing.

My question is, how does one sue the FDA?
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
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Re: FDA whistleblowing regarding unsafe medical devices

PostPosted by DCNGA » Mon Jan 30, 2012 2:31 pm

Since this is job related and in direct violation of a federal law that governs all federal offices, they can sue. Whether they win or even if their case is allowed to go forward, remains to be seen.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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