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
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| 1271.1 |
What are the purpose and scope of this part? |
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| 1271.3 |
How does FDA define important terms in this part? |
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| 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? |
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| 1271.15 |
Are there any exceptions from the requirements of this part? |
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| 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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| 1271.21 |
When do I register, submit an HCT/P list, and submit updates? |
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| 1271.22 |
How and where do I register and submit an HCT/P list? |
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| 1271.25 |
What information is required for establishment registration and HCT/P listing? |
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| 1271.26 |
When must I amend my establishment registration? |
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| 1271.27 |
Will FDA assign me a registration number? |
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| 1271.37 |
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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| 1271.45 |
What requirements does this subpart contain? |
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| 1271.47 |
What procedures must I establish and maintain? |
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| 1271.50 |
How do I determine whether a donor is eligible? |
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| 1271.55 |
What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? |
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| 1271.60 |
What quarantine and other requirements apply before the donor-eligibility determination is complete? |
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| 1271.65 |
How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited? |
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| 1271.75 |
How do I screen a donor? |
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| 1271.80 |
What are the general requirements for donor testing? |
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| 1271.85 |
What donor testing is required for different types of cells and tissues? |
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| 1271.90 |
Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply? |
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| 1271.145 |
Prevention of the introduction, transmission, or spread of communicable diseases. |
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| 1271.150 |
Current good tissue practice requirements. |
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| 1271.155 |
Exemptions and alternatives. |
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| 1271.160 |
Establishment and maintenance of a quality program. |
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| 1271.170 |
Personnel. |
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| 1271.180 |
Procedures. |
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| 1271.190 |
Facilities. |
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| 1271.195 |
Environmental control and monitoring. |
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| 1271.200 |
Equipment. |
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| 1271.210 |
Supplies and reagents. |
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| 1271.215 |
Recovery. |
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| 1271.220 |
Processing and process controls. |
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| 1271.225 |
Process changes. |
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| 1271.230 |
Process validation. |
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| 1271.250 |
Labeling controls. |
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| 1271.260 |
Storage. |
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| 1271.265 |
Receipt, predistribution shipment, and distribution of an HCT/P. |
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| 1271.270 |
Records. |
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| 1271.290 |
Tracking. |
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| 1271.320 |
Complaint file. |
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| 1271.330 |
Applicability. |
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| 1271.350 |
Reporting. |
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| 1271.370 |
Labeling. |
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| 1271.390 |
Applicability. |
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| 1271.400 |
Inspections. |
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| 1271.420 |
HCT/Ps offered for import. |
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| 1271.440 |
Orders of retention, recall, destruction, and cessation of manufacturing. |