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FDA Shoots For New 510(k) Modification Draft Guidance In 2016

The agency is taking another stab at clarifying its views on when a 510(k) is needed for a device modification in a draft guidance it hopes to issue next year, after having to abandon its 2011 effort in the face of stakeholder revolt. The device center's Michael Ryan previews what to expect.

FDA says it is making progress in its second shot at updating the widely used 1997 510(k) modifications guidance (K97)

after it was forced to abandon its first revision effort several years ago in the face of strong resistance from...

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