Chapter 63 – Overview of the FDA Regulatory Process

Publisher Summary This chapter provides a brief historical review of the Food and Drug Administration (FDA) and its organizational structure and discusses topics pertaining to the regulation of regenerative medicine products including possible regulatory pathways for combination products and relevant jurisdictional issues. FDA regulations are contained in the Code of Federal Regulations (CFR). Regulations for drugs, biologics, devices, and tissues, along with related regulations, may be found in various parts of Title 21 of the CFR. Guidance documents are nonbinding publications that describe the FDA's interpretation of policy pertaining to a regulatory issue or set of issues related to the design, production, labeling, promotion, manufacturing, and testing of regulated products, the processing, content, and evaluation, or approval of submissions inspection, and enforcement policies. Guidance documents, which are developed in accordance with Good Guidance Practices found at 21 CFR §10.115, are intended to clarify the FDA's current thinking related to regulatory issues and procedures. The FDA has issued “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products to assist establishments making donor eligibility determinations with complying with the Donor Eligibility rule (21 CFR 1271 Subpart C).” This guidance also incorporates and finalizes the content of “Guidance for Industry, Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt–Jakob Disease (CJD) and Variant Creutzfeldt–Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The US Public Health Service (PHS) agencies including the FDA, National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Health Resources and Services Administration (HRSA) have worked together to address the risk of infectious disease transmission, publishing the “PHS Guideline on Infectious Disease Issues in Xenotransplantation.”