7 questions to ask before submitting 501(k)

The FDA recently issued updates to its guidance for its “Refuse to Accept Policy for 510(k)s” for Center for Biologics Evaluation and Research-regulated (CBER) devices and for “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).”

Premarket Notification (510(k)) submissions for medical devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, by the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR).

The updated medical device guidance documents supersedes the previous documents issued in 2012 and 2015 and remain non-binding recommendations. In addition to explanation of the new policy, the new policy includes checklists for traditional, abbreviated and special 501(k)s. 

Once received in the Division, the 510(k) submission is assigned to the appropriate branch, and assigned to a lead reviewer, who conducts the Acceptance Review using the appropriate Acceptance Checklist in FDA’s Guidance titled Refuse to Accept Policy for 510(k)s. 

In the Acceptance Review, the reviewer determines whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.  

Within 15 days of receiving the submission, you will receive an electronic notification of the Acceptance Review result, which notify you of the name and contact information of the FDA Lead Reviewer assigned to your 510(k); and indicate the status of the submission

The updated guidance and checklists are intended to clarify the content needed for 510(k) submissions and provide more efficient approach to ensuring that safe and effective medical devices are made available to patients as quickly as possible. To that end, the agency will make a determination of acceptance of a within 15 calendar days of receipt of the submission.

Within that 15-day period the FDA staff should answer the preliminary questions, which are included on the first page of the Acceptance Checklists. The seven preliminary questions to be answered before the submission is compared to acceptance criteria include:

  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?
  4. Is the submission for a combination product that contains as a constituent part an approved drug that is under exclusive marketing rights? (503(g)(5))
  5. Is this device type eligible for a 510(k) submission?
  6. Is there a pending PMA for the same device with the same indications for use?
  7. If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy (AIP)?

Need help navigating the FDA submission process? Kapstone Medical has the experience and expertise across the full range of medical device manufacturing to get your submission accepted.

Visit our website or Call Us Today to learn more! Phone: (704) 843-7852 – email: info@kapstonemedical.com


Source: FDA Refuse to Accept Policy for 501(k)s


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