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

 
• By Sue Darcey

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.

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US FDA has made at least nine changes – some of which could be considered significant by sponsors – in a final 510(k) modifications guidance released by the agency Oct. 24, as compared to the proposed guidance issued in August 2016.

The final guidance replaces an oft-cited 1997 document for guiding company's decisions on it must submit a new 510(k) to support a device modification. It's been a controversial process to updating the policy, but FDA says the new guidance is meant to add more clarity to the decision-making process on a question comes up for almost every device company on a regular basis

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