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Updated Section 3610 Guidance

Client Alert | less than 1 min read | 05.01.20

Agencies continue to release and refine Section 3610 billing guidelines. There continue to be substantive differences between agencies, creating compliance challenges for contractors. Crowell & Moring continues to track the latest Section 3610 billing guidance. Click here to view the updated table, current as of May 1, 2020.

Insights

Client Alert | 6 min read | 09.03.26

FDA Seeks Input for Regulating GenAI-Powered Medical Devices

The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices. ...