Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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.
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