The purpose of this Part is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's).

In association with 21 CFR 211, for Cellular Products, Subpart D - Current Good Tissue Practice requires the following subparts in greater detail specific to Cellular Products:

Personnel; Procedures; Facilities; Environmental Control and Monitoring; Equipment; Supplies and Reagents; Recovery; Process Changes; Process Validation; Labeling Controls; Storage; Receipt, predistribution shipment, and distribution of an HCT/P; Records; Tracking; Complaint File.