title: Medical devices post-approval studies program: vision, strategies, challenges and opportunities.
authors.affiliation: Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.forename: Michele
authors.initials: M
authors.lastname: Bonhomme
authors.forename: Nilsa
authors.initials: N
authors.lastname: Loyo-Berrios
authors.forename: Thomas
authors.initials: T
authors.lastname: Gross
authors.forename: Robert
authors.initials: R
authors.lastname: Ciperson
authors.forename: Susan
authors.initials: S
authors.lastname: Gardner
authors.forename: Michael
authors.initials: M
authors.lastname: Marcarelli
mesh_terms: D003257:Consumer Product Safety; D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D015279:Organizational Culture; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D016730:Program Development; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration