viernes, 29 de mayo de 2026

Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance July 22, 2026

https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-content-human-factors-information-medical-device-marketing-submissions-final-guidance?utm_medium=email&utm_source=govdelivery Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties to discuss the final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions. This guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process. Date: July 22, 2026 Time: 1:00 – 2:00 p.m. ET Registration is not required.

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