FDA regulatory pathways for knee cartilage repair products.
Over the past 2 decades there has been significant progress in the treatment of articular cartilage pathology with the introduction of cell biology, tissue engineering, and biomaterials to address long standing challenges in this debilitating condition. However, cell therapies and products combining cells, other biologics, devices, and/or drugs do not easily fit within traditional regulatory frameworks of the US Food and Drug Administration (FDA) or agencies outside the United States. Regulations have evolved to specifically address these types of products in terms of their unique scientific and clinical issues. This paper reviews the characteristics of cell and combination products that distinguish them from more traditional medical devices and drugs, FDA regulatory pathways for marketing approval of these new types of products, and the implications of these regulations for orthopedic product development and practice.
Levine
David W
DW
Clinical Research Department, Genzyme, 55 Cambridge Parkway, Cambridge, MA 02142, USA. david.levine@genzyme.com
Mondano
Laura
L
Halpin
Michael
M
D001672:Biocompatible Materials; D002358:Cartilage, Articular / Q000601:surgery / Q000637:transplantation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D005260:Female; D033161:Government Regulation; D006801:Humans; D007719:Knee Joint / Q000601:surgery*; D008297:Male; D009983:Orthopedic Equipment; D011786:Quality Control; D023822:Tissue Engineering / Q000331:legislation & jurisprudence*; D054457:Tissue Scaffolds; D014481:United States; D014486:United States Food and Drug Administration
D001672:Biocompatible Materials