FDA Axes Controversial Plan On Med Device Safety Reports

By Jeff Overley (October 14, 2014, 2:02 PM EDT) -- The U.S. Food and Drug Administration on Tuesday abandoned a controversial proposal to force medical device makers to report minor product tweaks that aren't connected to recalls or serious safety concerns, an apparent bow to critics who called the policy overbroad.

The about-face was disclosed in a final guidance on how device manufacturers should distinguish between recalls and "product enhancements," and when they must file so-called 806 reports in connection with such actions. Last year, the FDA sparked widespread concern about creating paperwork burdens and new ammunition for product liability suits when it proposed requiring reporting of any enhancement intended to reduce...

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