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510(k) Modifications Guidance Docs Finalized At Long Last

Executive Summary

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.

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510(k) Modifications Guidance Shows FDA Focus On Least- Burdensome Principle, Routine Risk Tests

A final 510(k) modifications guidance released from US FDA contains at least nine changes in emphasis from an August 2016 proposal. It enunciates the agency's plan to abide by "the least burdensome principle" in evaluating sponsors submissions for changes, and it recommends that any decision by a company not to submit a new 510(k) after a device alteration be routinely verified and validated.

Industry Urges FDA To Distinguish Between 510(k) Modification Factors

Industry groups and companies said US FDA's August draft guidance is inappropriately intermixing two different standards for determining when a new 510(k) needs to be submitted for a device modification. Respondents to the draft guidance on 510(k) modifications are also looking for more clarity on FDA's expectations for companies to assess how cumulative changes to a device might trigger the need for a new submission. But overall, firms support the current draft more than the agency's abandoned 2011 attempt to revise its policy.

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Following up on recommendations made in her January report on duodenoscope contamination, Senate HELP Ranking Member Patty Murray, D-Wash., introduced a bill pressing FDA to accelerate its work to clarify when 510(k)s are needed for device modifications and to solidify the agency's authority to deny submissions if the sponsor fails to provide validated reprocessing data.

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