The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the information that should be included in premarket submissions to show EMC…
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Bill would expand access to digital therapeutics
Sens. Capito and Shaheen reintroduced the Access to Prescription Digital Therapeutics Act of 2023, aiming to expand access to FDA-approved software treatments for Medicare patients.
