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Framework for the Safety and Performance Based Pathway

Modernized pathway to facilitate 510(k) Submissions

Safety and Performance Based Pathway when: 

  • New device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than identified predicate
  • Predicate is within  scope of list of eligible device types
  • Performance criteria align with performance of predicate
  • New device meets all the FDA-identified performance criteria.

Impact:

  • Use pathway instead of conducting direct comparison testing to predicate despite technological differences
  • Will still need to identify a predicate for certain aspects of substantial equivalence, when appropriate.

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