The US FDA’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions.

Abbreviated 510(k) program for faster FDA clearance

FDA and CDRH have finalized the guidance on the Abbreviated 510(k) program, wherein manufacturers may utilize existing relevant FDA guidance documents, standards and special controls to qualify for expedited premarket notification review.

The final guidance identifies the content to be included in an Abbreviated 510(k) application, including device indications for use and labeling data, summary reports of how any relevant guidance, special controls or standards support substantial equivalence claims, and any supplementary information to address issues not covered by guidance, controls or standards.

FDA updates Refuse to Accept policy, reflects 510(k) pathway changes

US FDA has finalized guidance updates from early 2019 to the Refuse to Accept policy that establishes minimum acceptability thresholds for medical device 510(k) submissions. FDA’s Refuse to Accept (RTA) guidance includes acceptance checklists for traditional as well as Abbreviated and Special 510(k) application routes.

US medical device market applicants should stay up to date on FDA’s RTA policy in order to avoid potentially costly registration delays.