What is the FDA 510(k) RTA policy?

The FDA 510(k) Refuse to Accept (RTA) policy defines the minimum acceptance criteria a submission must meet before proceeding to substantive review.

What does the FDA 510(k) RTA checklist include?

The checklist covers administrative requirements, device description, intended use, labeling, performance testing, and applicable biocompatibility, sterilization, and software information.

How long does the FDA take to complete a 510(k) acceptance review?

The FDA aims to complete the initial 510(k) acceptance review within 15 calendar days of receiving the submission.

What happens if the FDA issues an RTA notification?

The manufacturer must address the identified deficiencies and submit the missing information under the originally assigned 510(k) number. FDA then conducts another acceptance review.

How can manufacturers avoid an FDA 510(k) RTA?

Manufacturers can reduce RTA risks by using the correct acceptance checklist, verifying all required sections, checking document consistency, and providing clear justifications for non-applicable items.