Improving medical device regulation: a work in progress

Affiliations

¹ University of California, San Francisco, School of Medicine, San Francisco.
² Maryland Department of Health and Mental Hygiene, The Office of the Secretary, Baltimore.

Comment

Elisabeth M Dietrich et al. JAMA Intern Med. 2014 Nov.

. 2014 Nov;174(11):1779-80.

doi: 10.1001/jamainternmed.2014.3211.

¹ University of California, San Francisco, School of Medicine, San Francisco.
² Maryland Department of Health and Mental Hygiene, The Office of the Secretary, Baltimore.

No abstract available

Comment on

Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices.
Zuckerman D, Brown P, Das A. Zuckerman D, et al. JAMA Intern Med. 2014 Nov;174(11):1781-7. doi: 10.1001/jamainternmed.2014.4193. JAMA Intern Med. 2014. PMID: 25265047
Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Reynolds IS, et al. JAMA Intern Med. 2014 Nov;174(11):1773-9. doi: 10.1001/jamainternmed.2014.4194. JAMA Intern Med. 2014. PMID: 25265209
The Food and Drug Administration's unique device identification system: better postmarket data on the safety and effectiveness of medical devices.
Rising J, Moscovitch B. Rising J, et al. JAMA Intern Med. 2014 Nov;174(11):1719-20. doi: 10.1001/jamainternmed.2014.4195. JAMA Intern Med. 2014. PMID: 25265502 No abstract available.