Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

TEXT PDF1271.1 What are the purpose and scope of this part?
TEXT PDF1271.3 How does FDA define important terms in this part?
TEXT PDF1271.3 How does FDA define important terms in this part?
TEXT PDF1271.10 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?
TEXT PDF1271.15 Are there any exceptions from the requirements of this part?
TEXT PDF1271.20 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?
TEXT PDF1271.21 When do I register, submit an HCT/P list, and submit updates?
TEXT PDF1271.22 How and where do I register and submit an HCT/P list?
TEXT PDF1271.25 What information is required for establishment registration and HCT/P listing?
TEXT PDF1271.26 When must I amend my establishment registration?
TEXT PDF1271.27 Will FDA assign me a registration number?
TEXT PDF1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?

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