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Technical considerations for development of medical devices employing physiologic closed-loop control technology to ensure safe and effective use in patients.
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on Hazard Analysis and Risk-Based Preventive Controls for Human Food.
This document provides FDA’s recommendations regarding premarket submissions of devices with cybersecurity risk.
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies