Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA Promises a Draft Guidance for Change Control for Artificial Intelligence in 2021,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
The U.S. FDA has issued an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms. There is no guarantee a final guidance will emerge before 2022, however, leaving developers with another year – perhaps longer – of uncertainty as to how to handle change control for their algorithms. …
Bradley Merrill Thompson of Epstein Becker Green told BioWorld at the time that a press release by then-FDA commissioner Scott Gottlieb avoided any mention of a need for new statutory authority. Gottlieb had already tendered his resignation, however, and thus any such remarks might have been treated with skepticism.