FDA Draft Guidance Document Addresses Acceptability of 510(k) Submissions

August 13, 2012—The US Food and Drug Administration (FDA) has issued a draft guidance document entitled the “Refuse to Accept Policy for 510(k)s,” the purpose of which is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The guidance is applicable to 510(k) submissions reviewed in the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. This draft guidance is not final nor is it in effect at this time.

The guidance document is available online and being distributed for comment purposes only, the agency advised. Comments and suggestions should be submitted within 45 days (September 27) of the August 13 notice in the Federal Register announcing the availability of the draft guidance. Written comments can be submitted by mail to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments can also be submitted electronically at www.regulations.gov.

Once finalized, the guidance document will replace two existing "Refuse to Accept" documents that were issued in 1993 and 1994. The current draft document states that the FDA has modified its 510(k) Refuse to Accept policy to include an early review against specific acceptance criteria, and to inform the submitter within the first 15 calendar days after receipt of the submission as to whether the submission is administratively complete or, if not, to identify the missing element(s). In order to enhance the consistency of the FDA's acceptance decisions and to help submitters better understand the types of information the FDA needs in order to conduct a substantive review, the guidance, which includes a set of checklists in the appendices, clarifies the necessary elements and contents of a complete 510(k) submission. 

The process that the document outlines will be applicable to all devices reviewed through the 510(k) notification process and has been compiled into these checklists for use by the FDA review staff.

The agency stated that it is critical to distinguish the completeness of the regulatory submission, the quality of the data provided, and any studies conducted in support of the submission. The assessment of the completeness of the 510(k) submission occurs during the acceptance review, while the assessment of the quality of the submitted information occurs during the substantive review. Acceptance will be based on the objective criteria outlined in the associated Acceptance Checklist and not on the quality of the data.

As summarized in the draft guidance, within 15 calendar days of receipt of a 510(k) submission, FDA staff should answer the five preliminary questions that are included on the first page of the Acceptance Checklists:

(1) Is the product a device (per section 201(h) of the Food & Drug Administration & C Act) or a combination product (per 21 CFR 3.2(e)) with a device constituent part?

(2) Is the application with the appropriate Center?

(3) Is a 510(k) the appropriate regulatory submission?

(4) Is there a pending PMA for the same device with the same indications for use?

(5) If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy?

Depending on the answers to these preliminary questions, the remainder of the acceptance review may or may not be necessary. If the responses to the preliminary questions and subsequent consultation with the appropriate Center personnel indicate that the 510(k) acceptance review should not continue, FDA staff should promptly notify the submitter using proper administrative procedure.

The FDA advised that it is focusing the agency's review resources on complete submissions, which will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. Also, with the medical device user-fee legislations of 2002, 2007, and 2012, the agency agreed to performance goals based on the timeliness of reviews. Acceptance review is important for both encouraging quality submissions from sponsors of 510(k) notifications and allowing the FDA to appropriately concentrate resources on complete submissions.