The FDA issued its final guidance on the human factors information that belongs in a device marketing submission on 29 May 2026, and this CDRH town hall — , 1–2 p.m. ET — is the agency's live Q&A on what the final version actually asks of manufacturers.

Dates and format

  • Date: 22 July 2026, 1–2 p.m. ET
  • Format: virtual town hall, joined via the link on the FDA event page
  • Subject: final guidance “Content of Human Factors Information in Medical Device Marketing Submissions,” issued 29 May 2026
  • Organizer: FDA Center for Devices and Radiological Health

What it covers

The guidance gives a risk-based framework for what human factors information CDRH expects in a marketing submission, complementing the agency's process guidance on applying human factors and usability engineering to devices. The town hall walks through the final version and takes questions — the fastest way to hear how reviewers read the document they will apply to your file.

Who should attend

Human factors and usability engineers, regulatory affairs professionals drafting 510(k), De Novo or PMA submissions, and design-assurance leads who decide what usability evidence a file carries. The user interface is where use error lives, and this hour tells you what the reviewer on the other side of your submission expects to find.

Looking past July? The MDUFA VI public meeting follows on 5 August, and the full events directory lists everything we have verified.

Frequently asked questions

How do I join the FDA human factors town hall?

The session is virtual, held 1–2 p.m. ET on 22 July 2026, and joined through the link on the FDA's event page. The FDA lists no registration fee.

Which guidance does the town hall discuss?

The final guidance “Content of Human Factors Information in Medical Device Marketing Submissions,” issued 29 May 2026. It sets a risk-based framework for the human factors information CDRH expects in a marketing submission.

Will there be a recording?

The FDA typically posts materials from CDRH town halls on the event page afterward, but the page does not state this for the 22 July session — check the FDA event page after the date.

Sources & further reading

  1. FDA. Town Hall — Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance, 07/22/2026. 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.