Medical devices post-approval studies program: vision, strategies, challenges and opportunities.
Marinac-Dabic
Danica
D
Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.
Bonhomme
Michele
M
Loyo-Berrios
Nilsa
N
Gross
Thomas
T
Ciperson
Robert
R
Gardner
Susan
S
Marcarelli
Michael
M
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