Substantial Equivalency: By Comparison or By Performance?

On April 12, FDA released a draft guidance document, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.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 a...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news