title: Medical device safety: FDA's postmarket transformation initiative.
authors.affiliation: FDA's Center for Devices and Radiological Health, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Schultz
mesh_terms: D003257:Consumer Product Safety; D004869:Equipment Safety; D006801:Humans; D015279:Organizational Culture; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration