FDA and MDIC Meet to Set Device Science Priorities

FDA's device center spent a full day this month asking industry, clinicians, researchers and patient groups a single question: what should the agency's regulatory science priorities look like for the next ten years? On 25 September 2026, the Center for Devices and Radiological Health (CDRH) and the Medical Device Innovation Consortium (MDIC) co-sponsored “Regulatory Science Innovations Catalyzing Medical Device Development,” an all-day public meeting at FDA’s White Oak campus. It is a planning exercise, not a decision — but the priorities it feeds into shape which review frameworks and guidance documents CDRH builds next.

Why a planning meeting is worth reading closely

CDRH does not usually hold a dedicated, day-long public meeting just to ask what its own research priorities should be. Guidance documents, review frameworks and new pathways generally start somewhere upstream of the docket that eventually proposes them — and a regulatory science research agenda is one of the places that happens. The three tracks FDA and MDIC built the day around — AI and digital health, emerging device technologies, and evidence generation and advanced testing methods — read as a fairly direct map of where CDRH expects review science to be tested hardest over the next several years: software-driven and AI-enabled devices, genuinely new device categories, and the nonclinical and real-world evidence methods sponsors will lean on to support them.

The partner running the room

MDIC is not a trade association and not a part of FDA. It is a 501(c)(3) nonprofit, public-private partnership founded in 2012 specifically to give FDA, device manufacturers, patients, researchers, clinicians and payers a shared table for regulatory science work that benefits from being done collaboratively rather than by any one party alone. Co-sponsoring a meeting like this with MDIC, rather than running it as a purely internal FDA exercise, is itself a signal: CDRH is treating the next decade’s research agenda as something industry and outside experts should help write, not just react to once it is published.

What is confirmed, and what is not

FDA’s own event page and agenda describe the meeting’s title, schedule, location and three-track structure, and that description is corroborated independently by legal-industry previews published ahead of the meeting. What is not yet public is a recap of what was actually said in the room — FDA has not published meeting minutes, named speakers, or specific commitments to a report or guidance document tied to a firm date. The concrete, confirmed next step for anyone who wants their views on the record is the open comment docket, which closes 24 November 2026. This piece will not speculate about what was decided at the meeting beyond what FDA has itself published about its purpose and structure.

Frequently asked questions

What did FDA and MDIC do on 25 September 2026?

CDRH and MDIC co-sponsored an all-day public meeting, "Regulatory Science Innovations Catalyzing Medical Device Development," 8:30 a.m.–4:30 p.m. ET at FDA's White Oak campus, with a virtual listen-only option, to help inform CDRH's regulatory science research priorities for the next decade.

What did the meeting cover?

An expert panel session followed by breakout discussions across three tracks: AI and digital health, emerging device technologies, and evidence generation and advanced testing methods.

What is MDIC?

The Medical Device Innovation Consortium: a 501(c)(3) nonprofit public-private partnership, founded in 2012, bringing together FDA, device manufacturers, patients, researchers, clinicians and payers on medical device regulatory science.

How do I comment, and by when?

Submit comments to Docket FDA-2026-N-8563 at Regulations.gov. FDA's event page states the docket remains open for 60 days after the meeting, putting the deadline at 24 November 2026.