Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was a featured guest on DarshanTalks, in the episode “The Impact of Clinical Decision Support Software on the Healthcare Industry.”
Following is a summary:
Bradley Merrill Thompson discusses with Darshan Kulkarni the implication of the Food and Drug Administration’s (FDA’s) final Clinical Decision Support (CDS) software guidance. The guidance provides clarity on FDA’s current thinking regarding the types of CDS functions that do not meet the definition of a device as amended by the 21st Century Cures Act.
- Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug and Cosmetic Act (FD&C Act) on December 13, 2016 removing certain software functions from the definition of a device in section 201(h) of the FD&C Act.
- In 2017, the FDA issued a draft guidance. A revised version of the draft guidance was issued in the year 2019. The final guidance was released in September, 2022.