FDA CDRH Webinars: Straight-From-the-Regulator Device Guidance

Disclaimer: Webinar schedules and registration may change. Check the official FDA CDRH Webinars page for the most current information.

FDA CDRH Webinars: Straight-From-the-Regulator Device Guidance

The FDA’s Center for Devices and Radiological Health (CDRH) runs a webinar program to explain its guidances, regulations, and policies directly to stakeholders. There is no more authoritative source on what the regulator actually expects, because the regulator is the one presenting.

The standard format is a presentation by an FDA official on a specific topic, followed by a live Q&A with stakeholders. Materials are typically posted afterward on CDRH Learn under “Specialty Technical Topics.”

Why it matters for HTM

The most consequential recent example is medical-device cybersecurity. The FDA’s final guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, was issued in its final form on June 27, 2025, and CDRH has held webinars walking through what it requires. For HTM and security leaders managing connected devices and pushing manufacturers on patching and SBOMs (software bills of materials), hearing the expectation framed by the FDA itself removes a lot of secondhand interpretation.

While much of CDRH’s audience is device manufacturers, the cybersecurity and post-market sessions are directly relevant to the hospital side, where HTM owns the devices these rules govern over their service life.

Who should tune in

HTM directors and device-security leaders, particularly anyone responsible for connected-device risk, vendor security requirements, or aligning a fleet to current FDA cybersecurity expectations. CIOs touching device security will find the cybersecurity sessions worthwhile.

Format and access

Live webinars with Q&A, plus on-demand materials (slides, transcripts, recordings) archived on the FDA site and CDRH Learn. The program is free. Topics follow regulatory activity rather than a fixed calendar, so the schedule is event-driven.

Logistics

• Format: Live webinars with Q&A, plus on-demand archived materials
• Host: U.S. FDA, Center for Devices and Radiological Health (CDRH)
• Cadence / next session: Event-driven, tied to new guidances; see host page
• Cost: Free
• Register: fda.gov

Bottom line

When the topic is a new device guidance or cybersecurity rule, this is the source, not a summary of the source. For HTM and security leaders, the cybersecurity sessions in particular are worth the time because they let you align your program to the regulator’s actual words. Watch the page around major guidance releases.

Visit the official FDA CDRH Webinars page for the schedule and registration.