Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: Pros and cons

Expert Review of Medical Devices

Volumn 6, Issue 2, 2009, Pages 137-145

  Bernad, Daniel Maxwell ^a  

^a UNIVERSITY OF OTTAWA   (Canada)

Author keywords

Humanitarian Device Exemption; Humanitarian Use Device; Medical device; Pediatric medical device; Product development; Regulatory system; Safety and Improvement Act of 2007

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DRUG MANUFACTURE; FEE; FOOD AND DRUG ADMINISTRATION; HUMANITARIAN DEVICE EXEMPTION; HUMANITARIAN USE DEVICE; LAW; MARKETING; MEDICAL DECISION MAKING; MEDICAL INFORMATION; MEDICAL INSTRUMENTATION; POSTMARKETING SURVEILLANCE; PRODUCT DEVELOPMENT; PROFIT; REIMBURSEMENT; SAFETY; STANDARDIZATION; APPARATUS, EQUIPMENT AND SUPPLIES; DECISION MAKING; FINANCIAL MANAGEMENT; GOVERNMENT REGULATION; HUMAN; UNITED STATES;

DECISION MAKING; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; GOVERNMENT REGULATION; HUMANS; MARKETING OF HEALTH SERVICES; ORPHAN DRUG PRODUCTION; UNITED STATES;

EID: 67449086858     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/17434440.6.2.137     Document Type: Article

References (14)

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