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 established a regulatory framework using risk-based criteria to determine whether such products will be regulated as medical devices, biologic drugs, or human tissue exempt from pre-market review.

HPM has tracked the development of FDA’s framework from its inception. We  assist companies desiring to market human cellular and tissue-based products with all aspects of the regulatory framework, including:

  • Establishment registration and listing
  • Donor screening and testing
  • Good tissue practices compliance
  • Product jurisdiction
  • Pre-market review strategy
  • Pre-market compliance
  • Post-market compliance

Related FDA Regulatory Categories