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FDA Issues Three Draft Guidance Documents In Ongoing Effort To Improve 510(k) Submissions

 
• By Brian Bossetta

As part of its ongoing effort to modernize its premarket notification 510(k) program, the US FDA has issued three draft guidance documents it says will improve the safety of critical medical devices and strengthen the submission process.

GUIDANCE COMPASS
• Source: Shutterstock

The US Food and Drug Administration says its 510(k) program needs to continue modernizing to improve the safety of medical devices, especially as technology becomes more complex and innovative.

To further that effort, the FDA published three draft guidance documents on 7 September that focus on three key areas of 510(k) submissions — predicate devices, clinical data, and implantable...

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