On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing, and mitigating performance changes over time (the “Request”).
The Request
Continue Reading FDA Requests Public Comment on Real-World Evaluation of AI-Enabled Medical DevicesThe Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices. The DHAC will discuss potential “benefits, risks to health, and risk mitigations” for
Continue Reading FDA to Convene Advisory Committee Meeting on GenAI Mental Health DevicesAs the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced its own intentions to aggressively scale the use of AI
Continue Reading Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
Continue Reading FDA Requests Comments on Substantial Proposed Changes to Data Standards
FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.” Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a
Continue Reading FDA Announces Workshop on AI Used In Drug & Biological Product DevelopmentOn March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle. The paper, entitled “
Continue Reading FDA Medical Product Centers Continue Focus on AI
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug
Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug DevelopmentInnovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to
Continue Reading 5 Reasons Digital Solutions for Women+ Health Will Grow in 2023On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool—a questionnaire designed to help mobile health app developers identify federal laws and
Continue Reading FTC, HHS, and FDA Update Tool to Help Mobile Health App Developers Understand Legal RequirementsOn 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and
Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices