Understanding food and drug administration regulatory requirements for an investigational device exemption for sponsor-investigators

Journal of Investigative Medicine

Volumn 60, Issue 7, 2012, Pages 987-994

  Holbein, M E Blair ^a   Berglund, Jelena Petrovic ^b  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Federal regulations; Food and Drug Administration; Investigational device exemption; Significant risk device

Indexed keywords

ARTICLE; CLINICAL STUDY; FOOD AND DRUG ADMINISTRATION; INVESTIGATIONAL DEVICE EXEMPTION; MEDICAL DEVICE; MEDICAL RESEARCH; PARAMETERS; PRACTICE GUIDELINE; CLINICAL TRIAL (TOPIC); DEVICE SAFETY; FUNDING; HEALTH CARE POLICY; HUMAN; INDUSTRY; MEDICAL DEVICE REGULATION; REGISTRATION; STUDY DESIGN;

DEVICE APPROVAL; HUMANS; RESEARCH PERSONNEL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85006173281     PISSN: 17088267     EISSN: 17088267     Source Type: Journal    
DOI: 10.2310/JIM.0b013e318262df40     Document Type: Article

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