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

Executive Summary

Industry groups and companies said US FDA's August draft guidance is inappropriately intermixing two different standards for determining when a new 510(k) needs to be submitted for a device modification. Respondents to the draft guidance on 510(k) modifications are also looking for more clarity on FDA's expectations for companies to assess how cumulative changes to a device might trigger the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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