21 C.F.R. PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart A--GENERAL PROVISIONS
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| What are the purpose and scope of this part?
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| How does FDA define important terms in this part?
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| 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?
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| Are there any exceptions from the requirements of this part?
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| 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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Subpart B--PROCEDURES FOR REGISTRATION AND LISTING
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| When do I register, submit an HCT/P list, and submit updates?
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| What information is required for establishment registration and HCT/P listing?
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| When must I amend my establishment registration?
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| Will FDA assign me a registration number?
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| 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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Subpart C--DONOR ELIGIBILITY
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| What requirements does this subpart contain?
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| What procedures must I establish and maintain?
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| How do I determine whether a donor is eligible?
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| What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
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| What quarantine and other requirements apply before the donor-eligibility determination is complete?
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| How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
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| What are the general requirements for donor testing?
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| What donor testing is required for different types of cells and tissues?
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| Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?
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Subpart D--CURRENT GOOD TISSUE PRACTICE
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| Prevention of the introduction, transmission, or spread of communicable diseases.
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| Current good tissue practice requirements.
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| Exemptions and alternatives.
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| Establishment and maintenance of a quality program.
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| Environmental control and monitoring.
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| Processing and process controls.
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| Receipt, predistribution shipment, and distribution of an HCT/P.
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Subpart E--ADDITIONAL REQUIREMENTS FOR ESTABLISHMENTS DESCRIBED IN 1271.10
Subpart F--INSPECTION AND ENFORCEMENT OF ESTABLISHMENTS DESCRIBED IN 1271.10
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| HCT/Ps offered for import.
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| Orders of retention, recall, destruction, and cessation of manufacturing.
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