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 expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final guidances have been published. Once the FDA begins to operationalize this pathway, a medical device manufacturer will have the option to meet FDA-identified performance criteria to demonstrate that its device is as safe and effective as a predicate device. The use of this pathway does not affect the FDA’s ability to request any information authorized by the statute or regulations.
This framework identifies five Class II device types for which the agency intends to establish performance criteria and testing methodology guidances ahead of launching the Safety and Performance Based Pathway:
The Safety and Performance Based Pathway is appropriate when FDA has determined that:
If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).