FDA Turns the Spotlight on Regulatory Science: What Medical Device Developers Need to Know

By Jennifer D. Newberger —

CDRH’s September 25 public meeting offers a front-row seat to the science shaping the future of medical device review.

Last week, the FDA’s Center for Devices and Radiological Health (CDRH) announced a public meeting titled “Regulatory Science Innovations Catalyzing Medical Device Development,” scheduled for September 25, 2026. For companies developing, manufacturing, or investing in medical devices, this event offers a rare opportunity to hear directly from the agency about the scientific tools and evidence standards that increasingly shape product review and approval decisions.

The day will open with an expert panel session before moving into deep-dive breakout discussions organized around three key focus areas: AI and digital health, emerging device technologies, and evidence generation and advanced testing methods. CDRH leadership and other key stakeholders are expected to participate throughout the day. These tracks signal the agency’s interest in structured industry input on how regulatory science should evolve to keep pace with fast-moving areas—AI/ML-enabled software, novel sensor and wearable technologies, and new approaches to generating clinical and non-clinical evidence—all of which carry direct implications for premarket strategy and submission planning.

The timing is significant. 2026 marks the 50th anniversary of the Medical Device Amendments of 1976—the statutory foundation of modern device regulation. Devices have evolved dramatically over the past half-century, and regulations have often struggled to keep pace. The agency’s current priorities—artificial intelligence, real-world evidence, cybersecurity, and updated quality management system requirements—are reshaping how submissions are prepared and evaluated. For medical device companies and their investors, this meeting presents a unique opportunity to gain insight into CDRH’s thinking on these critical topics and to provide feedback on how the regulatory framework should adapt to ongoing innovation.

We encourage clients to review the official FDA event page for registration details, format, and the full agenda. If you would like help interpreting how these regulatory science developments may affect your product pipeline, submission strategy, or compliance posture, please reach out to our team—we would be glad to assist.