Challenges in regulating breakthrough medical devices.
Muni
Neal I
NI
Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA), Rockville, MD, USA.
Gross
Thomas P
TP
Boam
Ashley B
AB
Wang
Stanley
S
Zuckerman
Bram D
BD
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004282:Documentation; D004869:Equipment Safety; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration