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The Federal Food and Drug Administration has revised its refuse-to-accept (RTA) policy for 510(k) submissions to clarify its guidance after the agency noted that its staff was spending too much time drafting extensive letters requesting additional information needed to conduct a substantive review of submitted applications.

According to the agency, the new guidance is intended to give FDA staff a clear and consistent approach for acceptance review for 510(k) applications and to outline the agency’s refuse-to-accept policy on 510(k)s. MEDIcept can help submitters prepare 510(k) notifications that are administratively complete for the FDA to conduct a substantive review.

The recently-issued final guidance noted that “focusing the FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.” To that end, the FDA instituted several significant changes affecting all applications that seek traditional, abbreviated, or special 510(k) clearance, including:

  • A government shutdown failsafe that stipulates if the government is closed during the 15-day review period (see below), the review period may be extended by the number of days closed
  • A new cybersecurity section has been added to the checklist
  • “Patient contact” has been made more specific, now referred to as “tissue contact,” and the biocompatibility assessment elements of the checklist have been expanded to specifically reference ISO 10993-1
  • Only “devices” and “accessories” are now referenced – “components” has been removed
  • Comparisons between subject and predicate devices previously required a comparison table “including features, materials, and principles of operation” – the phrase “technical specifications” has been added to this list

The guidance includes detailed checklists for devices submitted for 510(k) clearance. This consists of a 510(k) reviewer’s preliminary-questions checklist designed to inform the device manufacturer of the types of information reviewers will be seeking in their application review. The FDA’s revised policy “includes an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s).”

How a submission is organized and formatted must be part of a greater regulatory strategy to avoid unnecessary and expensive delays. With this updated 510(k) RTA guidance, MEDIcept’s team of medical device regulatory experts can assist medical device manufacturers with a better understanding of what FDA reviewers will be looking for in application submittals.