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FDA Looks To Expand Special 510(k) Program

 
• By David Filmore

US FDA released a draft guidance on the special 510(k) program in an effort to expand and improve the pathway.

FDA entrance sign 2016

Upcoming revisions to US FDA’s special 510(k) program could allow a wider set of submissions to qualify for the streamlined pathway, under which some 510(k)s, involving relatively minor device changes, can be cleared within 30 days if they are made by the same manufacturer as the original product.

US FDA announced updates to the program via a draft guidance document published Sept. 27. The changes are intended...

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