Recon: FDA releases draft guidance on gen AI-enabled devices; Industry warns Germany must reform drug pricing

Regulatory Reconnaissance highlights a mix of U.S. and international developments affecting medical technology, drugs, and public health. In the U.S., the FDA is seeking public feedback on its regulatory approach for generative AI-enabled medical devices, while J&J’s Monarch robot received FDA approval for AI-related features, and the agency named a second participant for a TEMPO digital health pilot. The briefing also notes FDA drug inspections have returned to pre-pandemic levels and covers a draft FDA drug repurposing pathway. Internationally, industry warns Germany may need to reform drug pricing to avoid losing pharmaceutical investment. Other items range from UK clinical trial eligibility rules to China’s opaque CAR-T death disclosure and India’s IND route for drugs.