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