Federal Register #FDA-2015-D-4599

FDA Issues Final Guidance on Human Factors Information for Medical Device Submissions

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final guidance document regarding human factors information in medical device marketing submissions. - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) - Purpose: - Provides a risk-based framework for manufacturers and FDA staff on the human factors information required in medical device marketing submissions - Aims to improve the efficiency and consistency of the FDA review process for medical devices - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or vendors are mentioned - Products/Services Requested: - No products or services are being procured; this is an informational guidance document - Unique/Notable Requirements: - Guidance is intended to support regulatory compliance for medical device submissions - Complements existing FDA guidance on human factors and usability engineering - Locations: - FDA offices in Rockville and Silver Spring, Maryland, are referenced as points of contact and oversight

Description

The Food and Drug Administration (FDA) has announced the availability of a final guidance document 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 marketing submissions to the Center for Devices and Radiological Health (CDRH). The goal is to facilitate the efficiency of the FDA review process for medical device marketing submissions. The guidance complements existing FDA guidance on human factors and usability engineering for medical devices.

View original listing