FDA regulatory pathways for knee cartilage repair products

Sports Medicine and Arthroscopy Review

Volumn 16, Issue 4, 2008, Pages 202-207

  Levine, David W ^a   Mondano, Laura ^a,b   Halpin, Michael ^a,b  

^a Clinical Research Department   (United States)

^b Regulatory Affairs Department   (United States)

Author keywords

Biologic; Cartilage repair; Cell therapy; FDA regulation

Indexed keywords

ACT; ARTICULAR CARTILAGE; BIOMEDICAL TECHNOLOGY ASSESSMENT; CELL THERAPY; CLINICAL PRACTICE; COST; FOOD AND DRUG ADMINISTRATION; KNEE; MARKETING; ORTHOPEDIC EQUIPMENT; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; TISSUE ENGINEERING; TISSUE REPAIR; TOTAL QUALITY MANAGEMENT; UNITED STATES;

BIOCOMPATIBLE MATERIALS; CARTILAGE, ARTICULAR; DEVICE APPROVAL; FEMALE; GOVERNMENT REGULATION; HUMANS; KNEE JOINT; MALE; ORTHOPEDIC EQUIPMENT; QUALITY CONTROL; TISSUE ENGINEERING; TISSUE SCAFFOLDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 57349149259     PISSN: 10628592     EISSN: 15381951     Source Type: Journal    
DOI: 10.1097/JSA.0b013e31818cdb97     Document Type: Review

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