US FDA Amends Refuse to Accept Policy for 510(k) Medical Device Submissions

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to implement changes to its Refuse to Accept (RTA) policy for 510(k) medical device submissions on October 1, 2015, according to new guidance from the agency.

The latest RTA policy guidance is intended by CDRH to add more clarity and improvements to the process, and to make it easier for 510(k) applicants to comply with the policy and provide “administratively complete” submissions to FDA reviewers.

As Emergo initially reported in late 2012 and early 2013, the RTA policy entails six preliminary questions followed by acceptance reviews for both traditional and abbreviated 510(k) submissions. Although the RTA guidance updates “do not represent significant changes to the prior version of the guidance,” states the FDA, 510(k) applicants should pay careful attention to RTA policy requirements to avoid delays in their US commercialization plans.

The policy revisions include streamlining and modification of acceptance checklist criteria to better align with actual 510(k) review practices. Richard Vincins, Vice President of Quality Assurance Consulting at Emergo, is encouraged by the RTA policy revisions based on the experiences of 510(k) applicants that have already undergone RTA reviews.

“Our experience from previous RTA letters included deficiencies noted by FDA reviewers that were difficult to locate or understand within the submission, so things like streamlining and page number references will be helpful,” says Vincins.

“We also had commonly experienced that the RTA process appeared to be a more rigorous review of the quality of 510(k) application content rather than the initial assessment for completeness and submission,” he adds.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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