FDA's Center for Devices and Radiological Health and the Medical Device Innovation Consortium (MDIC) co-host a hybrid public meeting on device regulatory science priorities — , 8:30 a.m.–4:30 p.m. ET, at FDA's White Oak campus with a virtual listen-only option — built around an expert panel and three breakout tracks.
Dates and format
- Date: 25 September 2026, 8:30 a.m.–4:30 p.m. ET
- Format: hybrid — in-person at FDA White Oak (registration closed 10 September) or virtual, listen-only (registration through 20 September)
- Docket: FDA-2026-N-8563, open for public comment through 24 November 2026
- Organizer: FDA CDRH, co-sponsored with the Medical Device Innovation Consortium (MDIC)
What it covers
The day opens with an expert panel before moving into deep-dive breakout discussions organized around three focus areas: AI and digital health, emerging device technologies, and evidence generation and advanced testing methods. The stated purpose is to inform CDRH's long-term research priorities and strategic planning — the kind of multi-stakeholder dialogue FDA uses to shape which regulatory science questions it invests in next, rather than a submission-specific workshop.
Who should attend
Regulatory science and policy leads tracking where CDRH's research agenda is heading, device developers working in AI/digital health or other emerging technology categories, and anyone weighing whether to submit a comment to the accompanying docket before it closes in November. Virtual listen-only access makes this reachable without travel, though the registration window closes five days after this listing's verification date.
FDA's public-meeting calendar keeps moving: the Vaccines and Related Biological Products Advisory Committee meets the following week on influenza strain selection, and the full events directory lists everything we have verified.
Frequently asked questions
When and where is the FDA/MDIC Regulatory Science Innovations meeting?
25 September 2026, 8:30 a.m.–4:30 p.m. ET, at the FDA White Oak Campus (Building 31 Conference Center, White Oak Great Room, Silver Spring, MD), with virtual listen-only attendance also offered.
Can I still register?
In-person registration closed 10 September 2026. Virtual (listen-only) registration remains open through 4:00 p.m. ET on 20 September 2026, per FDA's own event page.
Who organizes this meeting?
FDA's Center for Devices and Radiological Health (CDRH), co-sponsored with the Medical Device Innovation Consortium (MDIC), a public-private partnership focused on medical device regulatory science.
What does the meeting cover?
An opening expert panel session followed by breakout discussions on three focus areas: AI and digital health, emerging device technologies, and evidence generation and advanced testing methods — intended to inform CDRH's long-term regulatory science research priorities.
Is there a way to comment if I can't attend?
Yes. FDA opened public docket FDA-2026-N-8563 for stakeholder comments on the meeting's topics, open through 24 November 2026 at regulations.gov.
Sources & further reading
- FDA. Regulatory Science Innovations Catalyzing Medical Device Development, 09/25/2026. fda.gov
- FDA. Agenda: Regulatory Science Innovations Catalyzing Medical Device Development. fda.gov
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDA's own page and agenda PDF rather than a direct fetch, because this session's network egress could not reach fda.gov directly — confirm dates, registration status and access with FDA before making plans. Last verified 15 September 2026.
