The FDA recently selected the first participant for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The news release from July 22, 2026, identified Dexcom, Inc. as the first manufacturer selected for the TEMPO Pilot. Manufacturers selected for TEMPO intend to offer a device for use in providing care covered by CMS’s...Read More
The PMA CtQ pilot program aims to evaluate device design and manufacturing process quality information early on, giving the applicants the option of foregoing the standard PMA pre-approval inspectionRead More
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