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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