The FDA/CDRH has announced a public meeting titled, “Regulatory Science Innovations Catalyzing Medical Device Development.” The public meeting will take place on September 25, 2026 from 8:30 a.m. to 4:30 p.m. ET at the FDA White Oak Campus in Silver Spring, Maryland. Virtual attendance is available as well. Registration is free and available at the FDA event webpage. We encourage medical device developers and regulatory affairs professionals to register, as hearing agency perspectives in a public meeting is a beneficial learning experience.

The Regulatory Science Innovations Catalyzing Medical Device Development meeting is co-sponsored by the Medical Device Innovation Consortium (MDIC), and it will focus on advancing regulatory science for breakthrough and disruptive medical device technologies. The meeting objectives are:

• Gather stakeholder perspectives on emerging device technologies, evolving clinical scenarios, and their anticipated regulatory science needs
• Identify critical regulatory science gaps that could potentially impede the development of safe and effective novel devices and disruptive medical device technologies

The agenda and pre-meeting materials are not yet available, but the public docket to receive comments on stakeholder perspectives is available at regulations.gov, FDA-2026-N-8563. Stakeholders may submit comments regarding emerging device technologies and the identification of critical regulatory science gaps which are potentially impactful for the development of medical devices.