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 chemical characterization testing methodology, including extractions, used to address biocompatibility endpoints for medical devices.
Dates and format
- Date: 23 September 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
Chemical characterization is how a manufacturer finds out what could leach out of a device before toxicology decides whether it matters — and extraction study design is where submissions most often go wrong. The FDA's stated agenda is chemical characterization testing methodology to address biocompatibility endpoints, which in practice means extraction conditions, analytical approaches and how the resulting data feed the risk assessment. The Q&A is the point: CDRH staff answer submitted and live questions.
Who should attend
Biocompatibility and analytical chemistry leads designing extractables programs; toxicologists who inherit the data; and regulatory professionals deciding what a chemical characterization package must contain before a submission. An hour of direct CDRH Q&A costs nothing and routinely answers questions a deficiency letter would otherwise ask the hard way. The series continues with toxicological risk assessment on 7 October.
The next day, FDLI's webinar on the new National Drug Code format covers the drug side — and the full events directory lists everything we have verified.
Frequently asked questions
How do I join the FDA chemical characterization town hall?
The session is virtual, held 1–2 p.m. ET on 23 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. 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 follows CDRH's biocompatibility risk assessment town hall on 9 September 2026, and the series continues with toxicological risk assessment on 7 October 2026, per the FDA's CDRH events pages.
Sources & further reading
- FDA. Town Hall — Biocompatibility and Chemical Characterization Testing - Extractions, 09/23/2026. 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.
