Meeting | In Person

Event Title

Regulatory Science Innovations Catalyzing Medical Device Development

September 25, 2026

Date:: September 25, 2026
Time:: 8:30 a.m. - 4:30 p.m. ET

Attend

The Food and Drug Administration (FDA) is announcing a public meeting entitled “Regulatory Science Innovations Catalyzing Medical Device Development.” This meeting is co-sponsored with the Medical Device Innovation Consortium (MDIC). In conjunction with this meeting, the FDA is opening a docket to receive comments from the public.

The purpose of the meeting is to advance regulatory science in support of breakthrough devices and disruptive medical device technologies by fostering meaningful, multi-stakeholder dialogue to help inform long-term research priorities and strategic planning for FDA’s Center for Devices and Radiological Health (CDRH). Through this collaborative effort, CDRH and MDIC seek to identify the regulatory science challenges anticipated to impact medical device development over the next decade.

Meeting Objectives:

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

DATE AND TIME OF PUBLIC MEETING

September 25, 2026: The public meeting will take place from 8:30 a.m. to 4:30 p.m. ET

LOCATION OF PUBLIC MEETING

FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the White Oak Great Room, Silver Spring, MD 20993-0002

Virtual attendance (listening only) is available. The meeting link will be provided upon completion of registration.

AGENDA

Agenda and pre-meeting materials to be posted prior to the meeting.

REGISTRATION

Registration is free and available on a first-come, first-served basis.

In-person registration: Open through September 10, 2026

Virtual registration (listening only): Open until 4:00pm (ET) on September 20, 2026. The meeting link will be provided upon completion of registration.

Registrants will receive a confirmation email once their registration request has been accepted, if applicable. The FDA will update this webpage if in-person registration closes prior to the deadline.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact:

Brittany Caldwell
Office of Strategic Partnerships and Technology Innovation
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66
Silver Spring, MD 20993
CDRHRegScience@fda.hhs.gov

Requests for special accommodations should be submitted no later than September 10, 2026.

REQUEST FOR PUBLIC COMMENT

In conjunction with the public meeting, the FDA is opening a public docket for receiving comments on stakeholder perspectives of topics discussed during the meeting, including emerging device technologies and the identification of critical regulatory science gaps which are potentially impactful for the development of medical devices. Please submit all public comments to the docket [FDA-2026-N-8563, which will be available at regulations.gov]. The docket will remain open for 60 days following the meeting (closing November 24, 2026).

CONTACT

For questions about the meeting’s content, please contact: