title: Challenges in regulating breakthrough medical devices.
authors.affiliation: Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA), Rockville, MD, USA.
authors.forename: Neal I
authors.initials: NI
authors.lastname: Muni
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Gross
authors.forename: Ashley B
authors.initials: AB
authors.lastname: Boam
authors.forename: Stanley
authors.initials: S
authors.lastname: Wang
authors.forename: Bram D
authors.initials: BD
authors.lastname: Zuckerman
mesh_terms: 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