The U.S. Food and Drug Administration (FDA) has released a final version of a Guidance Document intended to assist medical device manufacturers in identifying the relevant human factors-related information to include in marketing submissions to the agency.
Published in late May, the Guidance Document, “Content of Human Factors Information in Medical Devices Marketing Submissions,” details a risk-based framework that manufacturers and FDA staff can use to determine which information related to a device’s human factors characteristics should be included in premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs) and humanitarian device exemption (HDE) applications.
The FDA says that the use of the information in this Guidance Document should be used in conjunction with the FDA’s guidance, titled “Applying Human Factors and Useability Engineering to Medical Devices.”
As a reminder, guidance documents issued by the FDA are not a substitute for applicable laws and regulations and are intended solely to provide information on the agency’s current perspective.