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?
TEXT PDF1271.45 What requirements does this subpart contain?
TEXT PDF1271.47 What procedures must I establish and maintain?
TEXT PDF1271.50 How do I determine whether a donor is eligible?
TEXT PDF1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
TEXT PDF1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?
TEXT PDF1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
TEXT PDF1271.75 How do I screen a donor?
TEXT PDF1271.80 What are the general requirements for donor testing?
TEXT PDF1271.85 What donor testing is required for different types of cells and tissues?
TEXT PDF1271.90 Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?
TEXT PDF1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.
TEXT PDF1271.150 Current good tissue practice requirements.
TEXT PDF1271.155 Exemptions and alternatives.
TEXT PDF1271.160 Establishment and maintenance of a quality program.
TEXT PDF1271.170 Personnel.
TEXT PDF1271.180 Procedures.
TEXT PDF1271.190 Facilities.
TEXT PDF1271.195 Environmental control and monitoring.
TEXT PDF1271.200 Equipment.
TEXT PDF1271.210 Supplies and reagents.
TEXT PDF1271.215 Recovery.
TEXT PDF1271.220 Processing and process controls.
TEXT PDF1271.225 Process changes.
TEXT PDF1271.230 Process validation.
TEXT PDF1271.250 Labeling controls.
TEXT PDF1271.260 Storage.
TEXT PDF1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
TEXT PDF1271.270 Records.
TEXT PDF1271.290 Tracking.
TEXT PDF1271.320 Complaint file.
TEXT PDF1271.330 Applicability.
TEXT PDF1271.350 Reporting.
TEXT PDF1271.370 Labeling.
TEXT PDF1271.390 Applicability.
TEXT PDF1271.400 Inspections.
TEXT PDF1271.420 HCT/Ps offered for import.
TEXT PDF1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.

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