What is the FDAs role in regulating Telemedicine?
The U.S. Federal Food and Drug Administration (FDA) plays a critical regulatory role in ensuring the safety and effectiveness of telemedicine medical devices and software with the Center for Devices and Radiological Health (CDRH) acting as lead agency. The Center is responsible for ensuring the safety and effectiveness of the medical devices used in telemedicine systems. The Center’s principal areas of responsibility are: premarket review, post market surveillance, quality systems, standards, and science relating to telemedicine. When equipment or software is intended for use in the diagnosis or treatment of a disease or other condition, FDA considers the equipment or software to be a medical device. FDA requires registration and listing, premarket notification and/or approval, good manufacturing practices, and post market surveillance. FDA also regulates the software used in telehealth systems. FDA provides guidance on medical imaging software, highlighting the distinction between pro
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