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Monday, June 17, 2013

FDA Tries Updating Device Guidance, Take Two.

by Nathaniel Weixel

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FDA is trying again to update a draft guidance on when a change made to an existing medical device requires the manufacturer to submit an entirely new 510(k)premarket notification, which grants marketing clearance. The agency held a public meeting June 13 to solicit comments from all stakeholders about what issues any potential guidance should address and how FDA could address them.

The guidance now in effect addresses 510(k) modifications, but it was issued in 1997. FDA first tried to update it in 2011, but ended up withdrawing the guidance last year after massive industry backlash. During the meeting, industry again seemed not to want a whole new update. They said the 1997 guidance works fine, and only needs some minor, targeted changes. Otherwise it would overly burdensome to submit a new application for even minor changes.

Patient and consumer advocates had a different view. They said the 1997 guidance is outdated. More importantly, they think FDA should be responsible for deciding when a new 510(k) is needed; the current guidance leaves it up to manufacturers.

FDA did not say when, or even if, it would come out with an updated guidance, but comments on the topics addressed at the meeting are due July 13.
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