title: Part II: Sealing holes in the safety net.
authors.affiliation: Centers for Education and Research on Therapeutics (CERTs) Coordinating Center, Duke Clinical Research Institute, Durham, NC 27705, USA. peter016@mc.duke.edu
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: John W
authors.initials: JW
authors.lastname: Hirshfeld
authors.forename: T Bruce
authors.initials: TB
authors.lastname: Ferguson
authors.forename: Judith M
authors.initials: JM
authors.lastname: Kramer
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Larry G
authors.initials: LG
authors.lastname: Kessler
mesh_terms: D001918:Brachytherapy / Q000295:instrumentation; D017147:Defibrillators, Implantable / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence; D019544:Equipment Failure Analysis; D004869:Equipment Safety / Q000592:standards*; D006353:Heart-Assist Devices / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000592:standards; D019736:Prostheses and Implants / Q000592:standards; D012042:Registries; D013525:Surgical Instruments / Q000592:standards*; D013903:Thoracic Surgery / Q000295:instrumentation*; D014481:United States