On April 12, FDA released a draft guidance document, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. Comments on the draft will be accepted until July 11. As comments are received they can be reviewed here.
An Abbreviated 510(k) is one that uses guidance documents, special controls, and/or FDA-recognized consensus standards to establish substantial equivalence in whole or in part without direct comparison of the candidate device to one or more predicate devices. The Abbreviated 510(k) has existed since at least 1998 as part of The New 510(k) Paradigm. The other two types of 510(k)s are Traditional and Special.
Device manufacturers may choose to submit an Abbreviated 510(k) when there are FDA-established performance criteria. As identified in the 510(k) database, there were 76 abbreviated 510(k)s cleared in 2017 and 17 in 2018 through April 20. Reviewing the corresponding product codes shows the applicable standards, but not guidances or special controls. The latter may be listed with the CFR regulation number. In some cases, multiple consensus standards are cited for the product code, and it is not clear from the public record whether the submission cited compliance with all of these, a subset, or just one. For example, the product code for an anti-snoring device that was cleared with an Abbreviated 510(k) under current rules lists three biocompatibility standards. It is perhaps noteworthy that no standards are listed for this product code (LRK) that relate to actual device performance. Similarly, the product code for a syringe cleared via an Abbreviated 510(k) (FMF) lists 18 separate standards.
Inherent in the Abbreviated concept is the notion that there must be both established performance requirements and associated test methods. The draft suggests that while the existing Abbreviated program allows for the use of established criteria to demonstrate equivalence for some performance characteristics, the new expanded program would involve demonstration that all of the performance characteristics necessary to support a finding of substantial equivalence have been met. This requires that such criteria be specifically enumerated by FDA. When there are such standards, FDA states in the draft that it intends to rely on a declaration of conformity by the submitter without the submission of actual data, although a summary of the data may be needed. However, FDA says that it can request the data as needed. When data does not have to be included, this should simplify the 510(k) itself, although not necessarily the underlying work.
An interesting question about reliance on the factors that allow for an Abbreviated 510(k) is whether the guidance document, special control, and/or standards capture all of the important factors that define the performance and substantial equivalency of a device. Of course, this question also applies to Traditional 510(k)s where it is assumed that some set of comparisons captures everything we need to know about real-world device performance. This reliance on a specific set of factors overlooks the fact that the actual demands of clinical performance may be different from often idealized, and always limited, test conditions. For example, the laboratory conditions of a mechanical fatigue test may not capture the variety of geometries and loadings that may occur in actual use. Similarly, human factors testing may miss actual conditions of use.
An Appendix to the draft describes the content of an Abbreviated 510(k) under the proposed expanded applicability. Most of this content is familiar. Notably, a substantial equivalency discussion is still required, including identifying a predicate device, but without the necessity for direct comparative testing. Similarly, such a 510(k) should include proposed labeling and information on sterilization and shelf life, biocompatibility, software, electromagnetic compatibility, and electrical safety.
The real appeal of the expanded Abbreviated 510(k) format may be that, when applicable, there will be specific performance criteria and, in some cases, corresponding test methods. While this reduces uncertainty about what needs to be measured, and how it needs to be measured, it may or may not mean less testing in comparison to a Traditional 510(k). Furthermore, the criteria for some devices could become more demanding compared with what you might otherwise have gotten away with. While the Traditional 510(k) would still be available, it seems unlikely, if not bizarre, that you could be successful doing less in support of a Traditional than you would be expected to do under an expanded Abbreviated. In this regard, “abbreviated” may in some cases prove to be a misnomer.
In order to implement this program after the comment period and any revisions that the comments may provoke, FDA will have to enumerate specific devices that the expanded Abbreviated 510(k) applies to, presumably in terms of their product codes, as well as establish the required performance criteria for each. This might take a while, although they may have some queued up.