FDA updates 'refuse-to-accept' policy

The FDA Sept. 13 updated its "refuse-to-accept" policy for 510(k) submissions for medical devices.

The updates are intended to give FDA staff a clear, consistent approach to 510(k) acceptance reviews and make it easier for devicemakers to ensure they turn in a complete application, according to Mass Device.

The new policy includes a detailed checklist for applicants seeking traditional, abbreviated and special 510(k) clearance.

The FDA said it will respond to applications within 15 calendar days from submission and will notify applicants if any information is missing. The FDA can notify an applicant any time within the 15 day period of their acceptance or refusal of the application.

If an application is approved, the FDA will begin a substantive review of the quality of information provided.

Read the full report here.

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