On September 25, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance that sets out the agency’s recommendations on nonclinical testing, clinical data, and labeling for premarket submissions involving certain robotically assisted surgical devices (RASDs). The FDA is accepting comments through November 24, 2026. Like all draft guidance, the document is not binding
Life Sciences
Information Sharing Between the SEC and the FDA on Regulated Products
By Ty Kayam, Eva Yin & Nawa Lodin on
On August 31, 2026, the Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a memorandum of understanding (MOU) governing the sharing of nonpublic information relating to FDA-regulated products and activities. The MOU is not limited to enforcement matters and expressly contemplates the SEC’s use of FDA information in carrying…
FDA Introduces a Potential Review Architecture for Generative AI-Enabled Medical Devices
By Ty Kayam & Jodi Daniel on
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health recently published a discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, offering one of the FDA’s most detailed articulations to date of how it may approach regulation of generative AI (GenAI)-enabled medical…