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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.