CDRH's town-hall series puts FDA reviewers on a live call to answer industry questions, and this session — , 1–2 p.m. ET — covers the risk-based framework for evaluating biocompatibility endpoints under the agency's ISO 10993-1 guidance, with worked examples.
Dates and format
- Date: 9 September 2026, 1–2 p.m. ET
- Format: virtual town hall, joined via the link on the FDA event page
- Question deadline: 31 July 2026 for questions to be considered in the discussion
- Organizer: FDA Center for Devices and Radiological Health
What it covers
Manufacturers evaluate biocompatibility endpoints using the risk-based framework in FDA's guidance on ISO 10993-1, and the agency's stated intention is to assess biocompatibility in the way that is least burdensome for industry and reviewers alike. This session shares risk-assessment approaches for evaluating those endpoints, with specific examples — and the Q&A is the point: CDRH staff answer submitted and live questions.
Who should attend
Biocompatibility, toxicology and preclinical leads preparing device submissions; quality engineers who own ISO 10993 test plans; and regulatory affairs professionals deciding how much testing a risk assessment can replace. An hour of direct CDRH Q&A costs nothing and routinely answers questions a submission cycle would otherwise ask the hard way. Related sessions follow on 23 September (chemical characterization) and 7 October (toxicological risk assessment).
Planning further ahead? The MedTech Conference 2026 runs in October, and the full events directory lists everything we have verified.
Frequently asked questions
How do I join the FDA biocompatibility town hall?
The session is virtual, held 1–2 p.m. ET on 9 September 2026, and joined through the link on the FDA's event page. The FDA lists no registration fee.
Can I ask CDRH a question during the town hall?
Yes — that is the format. Questions submitted to the FDA by 31 July 2026 are considered for the live discussion, and the session includes live Q&A with CDRH staff.
Is this town hall part of a series?
Yes. CDRH's biocompatibility town-hall series continues with chemical characterization and extractions testing on 23 September 2026 and toxicological risk assessment on 7 October 2026, per the FDA's CDRH Webinars page.
Sources & further reading
- FDA. Town Hall — Biocompatibility Risk Assessment, 09/09/2026. fda.gov
- FDA. CDRH Webinars — upcoming town halls and webinars. fda.gov
Event details are published by the organizer and can change. Confirm dates, format and access with the FDA before making plans. Last verified 16 July 2026.
