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This guidance makes recommendations on testing the safety of medical devices in the magnetic resonance environment and the safety information in the labeling.

This guidance document provides a description of the information to be included in a premarket notification for a magnetic resonance diagnostic device.

This guidance provides further standards for electronic 510(k) submission, a timetable for establishment of the standards, and criteria for waivers/exemptions.

Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”

This guidance provides recommendations regarding updating susceptibility test interpretive criteria (STIC)/breakpoints for antimicrobial susceptibility devices.

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on Hazard Analysis and Risk-Based Preventive Controls for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