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Compliance In Focus
Posted by John Lehmann on Wed, Aug 15, 2012

New: FDA Proposes 510(k) Refuse to Accept Policy

NEW 510K RTACurrently 510(k) applications are used to approve investigational devices that are largely equivalent to devices that the FDA has already approved. According to an article in MassDevice, The FDA issued new recommendations for improving the 510(k) medical device review process by installing a pre-review assessment that would check applications and reject submissions dubbed incomplete. The details can be found in FDA Draft Guidance: Refuse to Accept (RTA) Policy for 510(k)s.

The FDA will introduce a new pre-review assessment that will evaluate specific aspects of each application and inform within 15 days whether the submission is "administratively complete" or else identify the missing factors.

The agency has an early version of the new checklist it plans to use to assess an application, which includes basic criteria such as:

  • Submission contains table of contents
  • All pages of the submission are numbered
  • Inclusion of engineering drawings
  • Identification of predicate devices

The proposal is one of the FDA's attempts to make good on the promises it made to the medical device industry in the latest iteration of the Medical Device User Fee & Modernization Act.  The FDA had vowed to streamline its application review process in exchange for a doubling of fees that companies pay when submitting for review.

Since this was a collaborative effort between industry and the FDA, do you think the new guidelines will help?  Share your thoughts with us.

Photo Credit: duncan

Topics: Refuse to Accept Policy for 510(k)s, FDA, 510(k)


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