FDA recently issued its long-awaited final guidance document on the regulation of “clinical decision support” (CDS) software – tools that assist clinicians by analyzing patient data and generating corresponding notifications or recommendations.  FDA has added significant nuance to the criteria for qualifying as non-device CDS, which results in extending FDA’s authority over more CDS products. This poses challenges for industry with currently marketed products that have historically not been actively regulated by FDA.  This talk will focus on FDA’s updated interpretation of its authority to regulate CDS as more such products from all over the world are released in the U.S., including how manufacturers of currently marketed products should adapt to ensure they remain compliant.

BIO:

Suzanne Levy Friedman advises medical device companies on a wide range of activities across the life cycle of their products, including evaluating regulatory pathways, preparing submissions for FDA clearance or approval of new devices, advertising and promotion, and post-market product modifications. She focuses much of her practice on FDA's evolving paradigm for regulating software and digital health products, and she has helped clients determine whether they are regulated as the policies have shifted, and if so, how to appropriately bring their products to market.  Suzanne also frequently works on human tissue and combination products that combine a medical device element with a drug or a biologic. In conjunction, she helps advise clients on regenerative medicine and cell/gene therapies, which often raise questions that touch on multiple areas of FDA regulation