FDA Draft Guidance: Refuse to Accept 510(k) Policy

On August 13, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This guidance explains procedures and criteria FDA intends to use in assessing whether a 510(k) submission is administratively complete and should be accepted for substantive review. It’s primarily designed to identify missing or incomplete pieces of an application.

FDA will notify applicants of the outcome of this review within 15 days of receiving the 510(k) application. Once FDA receives the missing information, FDA has another 15 days to complete its acceptance review. (FDA won’t require a new submission for this, and there will be no additional user fee for the missing information.)

Preliminary questions in the review document include:

  • Is the product a device (per section 201(h) of the FD&C Act) or a combination product (per 21 CFR 3.2(e)) with a device constituent part?
  • If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy (AIP)?

More detailed review items seek clarification on the completeness of a variety of data, such as the inclusion of proposed labeling, declaration of conformity with design controls, a discussion of substantial equivalence, etc.

FDA will accept comments and suggestions regarding this draft document for 45 days from publication (August 13) in the Federal Register of the notice announcing the availability of the draft guidance. Electronic submissions may be entered at www.regulations.gov.


Draft Guidance – Refuse to Accept Policy for 510(k)s. August 13, 2012, FDA.gov.

Hyman, Phelps and McNamara, FDA Law Blog, FDA Issues New Refuse to Accept Policy for 510(k)s, Jennifer D. Newberger, August 13, 2012.