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510(k) Modifications Guidance Docs Finalized At Long Last

 
• By David Filmore

After years of controversy, US FDA finally succeeded in updating its 20-year-old guideline on when a new 510(k) is needed for device modifications. Split out as its own document is a guideline targeting the issue specifically for software modifications.

More than five years after it retracted its last attempt at updating its policy guidelines for when a 510(k) is needed to support a device modification, US FDA has reached the finish line in updating its frequently cited 1997 text on the subject.

The agency issued a final guidance document on "Deciding When to Submit a 510(k) for a Change to an Existing Device" on Oct. 24, alongside a similar guidance targeting software modifications for devices

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