What’s the Safety and Performance Based Pathway?

The Safety and Performance Based Pathway is a new regulatory pathway pertaining to the Premarket Notification 510(k) process and has been designed as part of U.S. Food and Drug Administration (FDA)’s efforts to modernize the 510(k) program.

This pathway proposed by the FDA can be seen as an option for manufacturers to “demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device”.  

The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) Program for “certain, well understood device types”. Manufacturers submitting an Abbreviated 510(k) leverage “conformity to FDA-recognized consensus standards, FDA guidance, and/or special controls to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence”. Similarly, the Safety and Performance Based Pathway includes the use of “robust versions of those same mechanisms, which contain all the performance characteristics necessary to support a finding of substantial equivalence for a device type, rather than using direct predicate comparison testing to support a finding of substantial equivalence for some of the performance characteristics.”

From today, the FDA has published four draft guidances and updated a final guidance document related to the Safety and Performance Based Pathway.

The Safety and Performance Based Pathway is appropriate when FDA has determined that:

  • The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
  • The new device meets all the FDA-identified performance criteria.

If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).

As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA has issued draft guidances identifying performance criteria and testing methodologies for certain devices within five class II device types.

The FDA will issue future final guidance(s) to apply this Safety and Performance Based Pathway to certain types of devices with corresponding FDA-identified performance criteria. It will be operationalised “once the first device types and applicable performance criteria have been identified and final guidances have been published.

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