Framework for the Safety and Performance Based Pathway
- What device types are eligible for the Safety and Performance Pathway
- Content of a Safety and Performance Based 510(k)
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional; Special; and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well understood device types.
For more information refer to the guidance Safety and Performance Based Pathway.
The Safety and Performance Based Pathway is appropriate when FDA has determined that:
- The new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate, and the predicate is within the scope of the list of eligible device types;
- The performance criteria align with the performance of one or more legally marketed devices of the same type as the new device; 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).
The FDA will issue future guidance to apply this Safety and Performance Based Pathway to certain types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which FDA should consider identifying performance criteria. For example, industry may suggest products 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. Input can be provided using the docket number FDA-2018-D-1387 at www.regulations.gov.
The FDA intends to maintain a list of device types appropriate for the Safety and Performance Base Pathway on this website, accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended in the guidances where feasible, and any other relevant information.
The amount and type of information necessary to support a finding of substantial equivalence under the Safety and Performance Based Pathway will depend on the underlying source for the performance criteria and testing methods. Table 1 and the Appendix within the guidance summarize the types of information that would be included in a submission based on the submitter's approach.
Importantly, 510(k) submitters will still need to identify a predicate for certain aspects of substantial equivalence. However, instead of conducting direct comparison testing to demonstrate that a device is as safe and effective as a predicate device despite technological differences, manufacturers will be able to use this pathway, when appropriate.
More information on content that would be included within a Safety and Performance Based 510(k) will be available in the device-specific guidances that will be issued under this pathway.