The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?
- PMID: 27437879
- DOI: 10.1001/jamacardio.2016.0002
The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?
Comment in
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The US Food and Drug Administration Premarket Approval Process and the 515 Program Initiative: View From a Panel Chair.JAMA Cardiol. 2016 May 1;1(2):119-20. doi: 10.1001/jamacardio.2016.0007. JAMA Cardiol. 2016. PMID: 27437880 No abstract available.
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