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# 2 Performance Based Pathway Guidances
- URL: https://www.fdaweb.com/2-performance-based-pathway-guidances/
- Published: 2022-04-12T12:00:00.000Z
- Updated: 2026-09-14T17:40:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151571

FDA has issued two guidances with performance criteria for products in support of the 510(k) Safety and Performance Based Pathway. The first [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/denture-base-resins-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com), *Denture Based Resins — Performance Criteria for Safety and Performance Based Pathway*, gives submitters an option to use the performance criteria proposed in the document to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

The second [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/facet-screw-systems-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com), *Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway*, gives the option to use the performance criteria for facet screw systems.