It sounds like the FDA is in a no win situation. First they are under fire by the Government Accountability Office for how it handles device recalls.
Snippet from the article:
The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency’s fast-track, 510(k) approval process.
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And then at the same time, the medical device industry is pressuring the FDA to hurry up.
Snippet from the article:
Despite recalls of defective medical devices that have caused devastating injuries and millions of dollars in medical costs, the Food and Drug Administration is under industry pressure to speed up its approval process.
Read the rest — Despite recalls, medical device industry presses FDA to speed up approval process