FDA 510(k) Refuse To Accept Policy

FDA Guidance: Refuse To Accept Policy for 510(k)s

On August 4, 2015, the FDA announced the availability of a guidance outlining the Agency’s updated Refuse to Accept policy for 510(k)s, that is scheduled to take effect starting October 1, 2015. This guidance will replace the current Refuse to Accept Policy for 510(k)s guidance, which was released in 2012, as well as the two guidances prior to that (the 1994 510(k) Refuse to Accept Procedures blue book memo & the 1993 Premarket Notification (510(k)) Refuse to Accept Policy).

The reason behind the Agency’s modifications to their approval criteria is to “enhance the consistency of our acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, this guidance, including the checklists included in the appendices, clarify the necessary elements and contents of a complete 510(k) submission.”

Based on the guidance document (that can be found here), the FDA’s Refuse to Accept (RTA) Principles include the following:

  • “Acceptance should not be based on a substantive review of the information provided in the 510(k) notification.”
  • “FDA staff should determine whether the submitter provided a justification for any alternative approach.”
  • “Device-specific and cross cutting guidance documents, applicable recognized standards, and applicable regulations will be considered when making an RTA determination.”

The document also states that FDA staff will answer the preliminary questions within 15 calendar days of receipt of the 510(k). The Agency anticipates these questions will be answered as an initial screening of the submission by the lead reviewer. The preliminary questions are:

  1. 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 subject to review in a 510(k)?
  2. Is the submission with the appropriate Center?
  3. If a Request for Designation (RFD) was submitted for the device or combination product with a device constituent part and assigned to your center, identify the RFD # and confirm the following:
  • Is the device or combination product the same (e.g., design, formulation) as that presented in the RFD submission?
  • Are the indications for use for the device or combination product identified in the 510(k) the same as those identified in the RFD submission?
  1. Is this device type eligible for a 510(k) submission?
  2. Is there a pending PMA for the same device with the same indications for use?
  3. If clinical studies have been submitted, is the submitted the subject of the Application Integrity Policy (AIP)?

Overall, a majority of the changes in the new guidance were made to various checklists and information included in the appendices, which help companies make sure they are submitting a complete application. For all of the details and to view the full guidance, click here.

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