Earlier this month, FDA issued a draft guidance: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. This draft guidance would expand use of the Abbreviated 510(k) pathway as follows: “The intent of the guidance is to describe an optional pathway for certain, well understood device types, where a submitter would 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.” Id. at 2.
The current Abbreviated 510(k) program allows a sponsor to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence by showing conformity to FDA-recognized consensus standards. In this guidance, FDA acknowledges that the current substantial equivalence analysis, which requires direct comparison testing can sometimes be very burdensome. For example, it is difficult to conduct comparison testing when a predicate device is not marketed or where it is prohibitively expensive. Another example is a device that relies on multiple predicate devices for different performance and technological characteristics may be required to conduct multiple comparative tests.
The draft guidance proposes an Expanded Abbreviated 510(k) program, in which sponsors would be able to utilize the same mechanisms available in the current Abbreviated 510(k) program to allow a demonstration of all performance characteristics. In some circumstances, no direct comparison testing would be required. A predicate device would still be identified, but testing of the proposed device would be conducted against objective performance criteria.
FDA plans to issue guidance documents to establish such performance criteria and identify the types of eligible devices. This guidance may include identification of products by product code, appropriate intended uses, appropriate indications for use, and expectations for technological characteristics.
This initiative should be considered a modest, but useful, tweak to the 510(k) program. While it may eventually ease testing burdens on well‑understood device types, FDA may require some time to issue a full panapoly of product-specific guidances. We suspect, though, that FDA has some devices in mind that it will address relatively quickly. Most device types will likely not be eligible for the program.
Anyone interested in submitting comments on the draft guidance must do so by July 11, 2018.