Medical devices post-approval studies program: vision, strategies, challenges and opportunities

Food Drug Law J. 2007;62(3):597-604.

Authors

Danica Marinac-Dabic¹, Michele Bonhomme, Nilsa Loyo-Berrios, Thomas Gross, Robert Ciperson, Susan Gardner, Michael Marcarelli

Affiliation

¹ Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.

PMID: 17915402

No abstract available

MeSH terms

Consumer Product Safety*
Device Approval*
Equipment Safety*
Humans
Organizational Culture
Product Surveillance, Postmarketing* / statistics & numerical data
Program Development*
United States
United States Food and Drug Administration / organization & administration