There are three types of Premarket Notification 510(k)s that may be submitted to the U.S. Food & Drug Administration (FDA): traditional, special and abbreviated. Under the recently finalized Safety and Performance Based Pathway guidance, FDA has expanded the Abbreviated 510(k) route for certain well-understood device types. The FDA expects to begin implementation of this pathway as soon as the device types and performance criteria are identified. Once implemented, a medical device manufacturer will be able to use performance criteria instead of direct comparisons to show substantial equivalence for qualifying devices.
Instead of having to conduct direct comparison testing to demonstrate a submitted device is as safe and effective as a predicate device, applicants will be able to use this new pathway when appropriate. Nevertheless, 510(k) applicants may still need to identify a predicate for certain aspects of substantial equivalence. The Safety and Performance Based Pathway is appropriate when FDA has determined that:
- the submitted device’s indications for use and technological characteristics do not raise different questions of safety and effectiveness from the identified predicate device;
- the performance criteria is related to the performance of at least one legally marketed device of the same type;
- the submitted device actually meets the performance criteria.
Until further guidance from FDA, the amount and type of information necessary to support a finding of substantial equivalence under this new pathway seems to depend on the totality of the circumstances. However, if any of these factors are not met, the applicant still has the option to submit a traditional, special or abbreviated 510(k).
The FDA will be creating a web-based list of device types appropriate for the Safety and Performance Based Pathway along with the guidance on the performance criteria and recommended testing methods for each device type. The agency plans on publishing all performance criteria appropriate for use under the Safety and Performance Pathway through guidance and special controls. In addition, the industry may suggest device types for FDA consideration. The FDA is actively encouraging the industry to submit evidence-based suggestions on what performance criteria should be used and on the types of eligible devices.