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General Provisions

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Regulations Under Certain Other Acts Administered by the Food and Drug Administration
  6. Human Cells, Tissues, and Cellular and Tissue-Based Products
  7. General Provisions

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Section
1271.1

What are the purpose and scope of this part?

Section
1271.3

How does FDA define important terms in this part?

Section
1271.10

Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?

Section
1271.15

Are there any exceptions from the requirements of this part?

Section
1271.20

If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?

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