The Safety and Performance Based Pathway is appropriate when the FDA has determined:
If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).
The following final guidances identify performance criteria and testing methodologies for device types that are appropriate for this pathway:
The FDA will continue to issue draft and final guidance(s) to apply this Safety and Performance Based Pathway to additional types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which the FDA should consider identifying performance criteria. For example, industry may suggest devices for which there are comprehensive FDA-recognized consensus standards. We encourage industry and other stakeholders to submit evidence-based suggestions on what the performance criteria should be for eligible device types.
The FDA issued draft guidances identifying performance criteria and testing methodologies for the following device types. Once these guidances are finalized, submitters will have the option to use the safety and performance based pathway for these device types.