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 toxicological risk assessments used to address biocompatibility endpoints for medical devices.
Dates and format
- Date: 7 October 2026, 1–2 p.m. ET
- Format: virtual town hall, joined via the link on the FDA event page
- Questions: emailed to CDRH, considered for the live discussion
- Organizer: FDA Center for Devices and Radiological Health
What it covers
The toxicological risk assessment is where a biocompatibility file becomes an argument: chemical characterization data in, endpoint-by-endpoint safety conclusions out. This session covers how those assessments should address biocompatibility endpoints — the judgment calls on exposure, thresholds and toxicological rationale that determine whether testing can be reduced or must be run. The Q&A is the point: CDRH staff answer submitted and live questions.
Who should attend
Toxicologists writing device risk assessments; biocompatibility leads deciding between testing and justification; and regulatory professionals defending those choices in submissions. An hour of direct CDRH Q&A costs nothing and routinely answers questions a deficiency letter would otherwise ask the hard way. It pairs naturally with the chemical characterization session on 23 September, which covers the data this assessment consumes.
In the same month, ISPE's visual inspection webinar runs on 1 October — and the full events directory lists everything we have verified.
Frequently asked questions
How do I join the FDA toxicological risk assessment town hall?
The session is virtual, held 1–2 p.m. ET on 7 October 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. The FDA invites questions by email to CDRH for possible discussion during the session, and the town hall includes live Q&A with agency staff.
Is this town hall part of a series?
Yes — it closes CDRH's autumn biocompatibility sequence, after risk assessment on 9 September and chemical characterization and extractions on 23 September 2026, per the FDA's CDRH events pages.
Sources & further reading
- FDA. Town Hall — Biocompatibility and Toxicological Risk Assessment, 10/07/2026. fda.gov
- FDA. CDRH Events — 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 19 July 2026.
