Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

FDA Details When Human Factors Testing Is A Must

This article was originally published in The Gray Sheet

Executive Summary

FDA identified the device types that almost always need human factors, or usability, data included in premarket submissions in a draft guidance posted in conjunction with final guidelines with broader human factors testing recommendations.

Advertisement

Related Content

Clinical Trial Design, Precision Medicine Added To CDRH Science Priorities
In Case You Missed It: Top 10 Gray Sheet Stories In February
FDA Guidance Sheds Light On Human Factor Studies For Combo Products
FDA To Clarify Scope Of Devices Covered By Human Factors Guidance
Factoring In Human Factors: An Interview With Peter Carstensen

Topics

Advertisement
UsernamePublicRestriction

Register