An FDA viewpoint on unique considerations for medical-device clinical trials

New England Journal of Medicine

Volumn 376, Issue 14, 2017, Pages 1350-1357

  Faris, Owen ^a   Shuren, Jeffrey ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTIFICIAL HEART PACEMAKER; BLOOD GLUCOSE METER; CLINICAL EFFECTIVENESS; COMPRESSION BANDAGE; CONDOM; DENTAL FLOSS; ENGINEERING; FOOD AND DRUG ADMINISTRATION; HEART VALVE PROSTHESIS; HUMAN; INTRAUTERINE CONTRACEPTIVE DEVICE; LAW; MARKETING; MEDICAL DEVICE; NEBULIZER; NUCLEAR MAGNETIC RESONANCE IMAGING; NUCLEAR MAGNETIC RESONANCE SCANNER; ORAL THERMOMETER; OUTCOME ASSESSMENT; REVIEW; RISK BENEFIT ANALYSIS; SAFETY; SPECTACLES; UNITED STATES; CLINICAL TRIAL (TOPIC); DEVICE APPROVAL; METHODOLOGY; PROCEDURES; STANDARDS;

CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; HUMANS; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85017319103     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMra1512592     Document Type: Review

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