Human Cellular and Tissue-Based Products
Advancing knowledge of the functional characteristics and potentials of human cells and tissues has led to rapid growth in the research and development of therapeutic products derived from these materials. FDA has established a regulatory framework which uses risk-based criteria to determine whether such products will be regulated as medical devices, biologic drugs, or human tissue exempt from pre-market review. Other regulatory requirements include establishment registration and listing, donor screening and testing, and compliance with good tissue practices akin to the good manufacturing practices for conventional drugs and devices. HPM has tracked the development of FDA's framework from its inception. HPM attorneys assist companies desiring to market human cellular and tissue-based products with all aspects of the regulatory framework, including product jurisdiction and pre-market review strategy, the pre-market review process, and pre- and postmarket compliance.
Developments in the Law