unr.edu

120. Investigational Device Research and Exempted Device Investigations

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 ...
Fierce Healthcare

CMS touts transparency and expediency in finalized transitional medical device coverage program

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 ...
TCTMD

European Transition from Medical Device Director (MDD) to Medical Device Regulation (MDR): Roadmap for the Future of Global AF Studies

Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...
unr.edu

130. Emergency, Compassionate, Treatment, and Continued Uses of Investigational Devices

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 ...