For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...
The Centers for Medicare & Medicaid Services (CMS) released a final procedural notice on Wednesday to expedite Medicare coverage of novel medical devices and get the devices to Medicare beneficiaries ...
FDA and the University IRB recognize there may be circumstances for a health care provider to use an unapproved or investigational device to save the life of a patient or to help a patient suffering ...
The "UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course (Apr 15, 2026)" training has been added to ResearchAndMarkets.com's offering. This course, designed for medical device ...
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