Bradley Merrill Thompson, Strategic Advisor with EBG Advisors and Member of the Firm at Epstein Becker Green, was quoted in BioWorld, in “FDA Draft Guidance for AI Change Control Shifts Workload to Initial Premarket Filing,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
Developers of artificial intelligence (AI) and machine learning (ML) algorithms have found themselves returning repeatedly to the U.S. FDA for seemingly modest updates to their products, a problem that may soon be relieved by an FDA draft guidance on predetermined change control for AI and ML. However, Brad Thompson of Epstein, Becker & Green, P.C., told BioWorld that the terms of the draft “hugely increases the burden on developers to plan ahead” in order to obtain that postmarket relief from repeated 510(k) filings, a concession that device manufacturers and software developers may be more than willing to make.
