In recent years FDA has initiated alternative programs for demonstrating substantial equivalence including the Special 510(k) and the Abbreviated 510(k). Additionally, Congress took action when it amended the Food Drug and Cosmetic Act to add what are known as the “least burdensome” provisions requiring the Agency to request only the minimum information necessary to adequately address a regulatory question or issue during their consideration.
With substantial equivalence, FDA requires the submitter of a 510(k) to demonstrate that despite technological differences, it’s device is as safe and effective as a device that is already legally on the market as demonstrated by performance expectations described in FDA guidance, FDA-recognized consensus standards, and/or special controls. In the new Guidance, 510(k) submitters have the additional option of demonstrating equivalence through a Safety and Performance Based Pathway whereby a submitter would use, at least in part, robust performance characteristics to demonstrate substantial equivalence instead of comparison testing to a predicate device. Submissions under the Safety and Performance Based Pathway must by in compliance with premarket notification requirements for substantial equivalence found in 21 CFR 807.87.
According to FDA, “use of performance criteria is only 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.
- The performance criteria align with the performance of one or more legally marketed devices of the same type as the new device.
- The new device meets all the performance criteria….”
Says the Agency, “if a device cannot rely entirely on performance criteria identified by FDA to demonstrate substantial equivalence for its submission, it is not appropriate for this program.”
While FDA has not yet provided the types of devices appropriate and would apply for the Safety and Performance Pathway, the Agency has announced that submitters using this Pathway must include a Declaration of Conformity to an FDA-recognized consensus standard, testing protocols, a results summary, and/or underlying data (i.e., complete test report), as appropriate, or in the event that the new device is seeking to establish equivalence with a predicate device, a Declaration of Conformity in most cases would be sufficient. Additionally, FDA recommends 510(k) submissions using this Pathway include the same 21 section headers of a traditional 510(k) submissions, in the same specified order, and suggests retaining headers even in cases where the item is not applicable. Bear in mind that at any time, FDA may request the data used to support a 510(k) submissions. In cases where they Agency determines that performance equivalence has not been demonstrated, the submitter may revert to other means of means of 510(k) submission to demonstrate substantial equivalence.
It is not too soon to begin prepping 510(k) submissions with initial background information prior to submission including a determination of which predicate device is most appropriate for your product. Consult with a qualified expert consultant for assistance in design and testing protocols as well as data reviews and preparation of 510(k) submissions. Ensuring submissions are appropriately prepared and data vetted can facilitate FDA’s review and favorable determination.
Regulatory Updates
