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 clarify and improve the submission process, making it easier for 510(k) applicants to comply with the policy and provide submissions to FDA reviewers that are complete according to their administration guidelines.

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.