Medmarc Blog (blog.medmarc.com)
Machine Learning
FDA Product Centers Collaborate on AI Draft Guidance
The U.S. FDA posted a draft guidance for AI-enabled device software functions (DSFs) in January 2025, which provides much-needed clarity for a number of product types. All three of the agency’s...
AI Regulation Lagging Behind Innovation and Creating Friction
Developers of artificial intelligence (AI) products have moved quickly into a wide range of product types, but regulatory agencies are struggling to keep pace. One of the issues for industry is that...
H.R. 1 Restores Deductibility of Research and Development Expenses
Both chambers of the U.S. Congress have passed House Resolution 1 (H.R. 1), which offers several significant tax benefits for companies in the life sciences industry. One of the most important of...
Regulatory Partners Release guidelines for PCCPs
The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...
AdvaMed and CapView Propose Plan for Medicare Coverage of AI
The Advanced Medical Technology Association (AdvaMed) and CapView Strategies have collaborated to produce a series of recommendations for improving Medicare coverage of artificial intelligence (AI),...
FDA Seeks Feedback on AI in Drug Development, Manufacturing
The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...