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.
- 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.