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Compliance In Focus
Posted by John Lehmann on Thu, Oct 11, 2012

510(k) RTA - Did FDA Shoot and Miss?

510(k) RTA  Did FDA Shoot and MissIt wasn’t too long ago that new recommendations for improving the 510(k) medical device review processes were published with the goal of installing a pre-review assessment that would check applications and reject submissions dibbed incomplete.  FDA took steps forward with this plan and released the FDA Draft Guidance: Refuse to Accept Policy for 510(k)s (RTA).

FDA’s goal with RTA is to help streamline the review process, and hopefully grant faster approvals. The applications submitted would be pre-reviewed for based administrative completeness including criteria:

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

However, recently industry has fired back claiming FDA’s guidance is not objective and could be more time consuming then the current review process. While FDA made it clear RTA is not meant to review the innovative products- rather just ensure completeness with submission- many feel that the checklists are too detailed and too subjective to really help both parties.

510(k) remains to be a hot topic across industry leaders. While it seems FDA is trying to make steps forward, others view them as steps in the wrong direction. To better understand the 510(k) process checkout the whitepaper, “510(k) Current Status & Considerations” and gain a better perspective on these types of submissions.

Have you had a chance to look at FDA’s draft guidance? Do you agree that this will become more burdensome then helpful?

Photo Credit: Kilgub

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

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