Understanding external controls over the commercial introduction of engineered human tissues. Assessing regulatory and liability issues

Emerging biomedical technologies present a new order of magnitude of complexity in their interactions with human patients. As such, they challenge established processes for protecting patients and the public health, while testing the capacity of those processes to ensure timely access to beneficial therapies--especially those representing significant advances over existing therapies. This article reviews the Food and Drug Administration (FDA) regulatory process--including the classification of medical products, the marketing review and approval pathways, and the 1997 FDA Modernization Act--and discusses other legal and policy considerations relevant to engineered tissues.