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, Industry Coalition Still at Odds Over September 2022 CDS Final Guidance,” by Mark McCarty. (Read the full version – subscription required.)

Following is an excerpt:

The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.

The September 2022 CDS final guidance featured several omissions and additions relative to the 2019 draft version, which was the second version in two years to be issued by the agency. Brad Thompson of Epstein Becker & Green P.C., (EBG) the law firm representing the CDS Coalition, took square aim at the final guidance last year as a failure to comply with the terms of the 21ste Century Cures Act’s restrictions of the definition of a regulated device. The fact that the guidance was in final form prompted the Coalition in early February to sponsor a citizen’s petition to have the FDA withdraw the final and revisit some of the controversies, such as the withdrawal of a risk classification mechanism developed in 2014 by the International Medical Device Regulators Forum (IMDRF).

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