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

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Industry groups and companies said US FDA's August draft guidance is inappropriately intermixing two different standards for determining when a new 510(k) needs to be submitted for a device modification. Respondents to the draft guidance on 510(k) modifications are also looking for more clarity on FDA's expectations for companies to assess how cumulative changes to a device might trigger the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

US FDA's August draft guidance on 510(k) modifications confusingly intermixes what are supposed to be two distinct factors for deciding whether a new submission is necessary, industry stakeholders say. Companies also call for the agency to update its language in the draft to remove the suggestion that manufacturers must repeatedly assess and document every incremental change to a 510(k)-cleared device to evaluate the cumulative impact of recent changes.

The 510(k) modifications draft, released Aug. 5, stressed that FDA wants device sponsors to complete risk-based assessments on changes they...

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