FDA 21 CFR 1271: Human Cells, Tissues, and Cellular and Tissue-based Products, 4/12

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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.

For directﾠapplication to computers and software, see sections:

• 1271.160(d) Computer Validationﾠ
• 1271.270(c) Record Retention