How does medical device regulation perform in the United States and the European union? A systematic review

PLoS Medicine

Volumn 9, Issue 7, 2012, Pages

  Kramer, Daniel B ^a,b   Xu, Shuai ^a   Kesselheim, Aaron S ^a,c  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DATA EXTRACTION; DEVICE APPROVAL; DEVICE RECALL; DEVICE SAFETY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; INDUSTRY; MEDICAL DEVICE; OUTCOME ASSESSMENT; POSTMARKETING SURVEILLANCE; REVIEW; SYSTEMATIC REVIEW; UNITED STATES; DEVICES; LEGAL ASPECT; META ANALYSIS; SOCIAL CONTROL; STATISTICS;

EQUIPMENT AND SUPPLIES; EUROPEAN UNION; HUMANS; MEDICAL DEVICE RECALLS; PRODUCT SURVEILLANCE, POSTMARKETING; SOCIAL CONTROL, FORMAL; UNITED STATES;

EID: 84864422985     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001276     Document Type: Review

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