Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

Journal of Medical Devices, Transactions of the ASME

Volumn 6, Issue 2, 2012, Pages

  Pietzsch, Jan B ^a,b   Zanchi, Marta G ^a,c   Linehan, John H ^b,d  

^a Wing Tech Inc   (United States)

^b STANFORD UNIVERSITY   (United States)

^c Medinnovo LLC   (United States)

^d Northwestern University   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GUIDANCE DOCUMENT; INDUSTRY EXPERIENCE; INTERNATIONAL COMPARISON; INVESTMENT DECISIONS; MEDICAL DEVICES; MEDICAL TECHNOLOGIES; POLICY DISCUSSION; REGULATORY PATHWAY; REGULATORY PROCESS; REGULATORY REQUIREMENTS; SMALL COMPANIES; SURVEY DATA;

BIOMEDICAL ENGINEERING; BIOMEDICAL EQUIPMENT; INNOVATION; INVESTMENTS; PERSONNEL TRAINING; SURVEYS;

PERSONNEL;

ARTICLE; COMMERCIAL PHENOMENA; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; INDUSTRY; LAW; MATERIALS MANAGEMENT; MEDICAL DEVICE; MEDICAL TECHNOLOGY;

EID: 84861513928     PISSN: 19326181     EISSN: 1932619X     Source Type: Journal    
DOI: 10.1115/1.4006781     Document Type: Article

References (22)

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