FDA Internal Pilot Program for 510k Review

The FDA is running a pilot program, April 2nd to October 2nd 2012, for review of 510(k) applications.  It is an internal program designed with the following objectives:

  1. Two Tiered Review
    • Quick Review Tier
      • Good Quality submissions can clear as soon as possible but within 30 days
      • Must pass Quick Review Criteria
      • Pass a Total Product Life Cycle (Postmarket) Search
      • Seek clearance for a device for which FDA has review experience and knowledge of expected performance
      • Not need an extensive consult to complete 510(k) review
      • Contain a 510(k) Summary and not a 510(k) Statement
    • Regular Review Tier
      • Normal 510(k) review, clear within 90 days
  2. Reduce the review time of Traditional 510(k) applications that are of good quality
    • Creates an incentive to sponsors to submit good quality applications to OIVD
  3. Diminish the effort and time reviewers dedicate to Traditional 510(k) applications for products that are well known to the Office
  4. Attain faster product availability
  5. Increase reviewer time for other work-related activities such as training/continuing education, or other regulatory activities

Pilot Triage Flowchart

For more:  PROPOSED PILOT TRIAGE PROGRAM

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