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 PDF1271.10 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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