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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter L - Regulations Under Certain Other Acts Administered by the Food and Drug Administration |
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Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products |
| Subpart A - General Provisions |
| § 1271.1 - What are the purpose and scope of this part? |
| § 1271.3 - How does FDA define important terms in this part? |
| § 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? |
| § 1271.15 - Are there any exceptions from the requirements of this part? |
| § 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? |
| Subpart B - Procedures for Registration and Listing |
| § 1271.21 - When do I register, submit an HCT/P list, and submit updates? |
| § 1271.22 - How do I register and submit an HCT/P list? |
| § 1271.23 - How is a waiver from the electronic format requirements requested? |
| § 1271.25 - What information is required for establishment registration and HCT/P listing? |
| § 1271.26 - When must I amend my establishment registration? |
| § 1271.27 - Will FDA assign me a registration number? |
| § 1271.37 - Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings? |
| Subpart C - Donor Eligibility |
| § 1271.45 - What requirements does this subpart contain? |
| § 1271.47 - What procedures must I establish and maintain? |
| § 1271.50 - How do I determine whether a donor is eligible? |
| § 1271.55 - What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? |
| § 1271.60 - What quarantine and other requirements apply before the donor-eligibility determination is complete? |
| § 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? |
| § 1271.75 - How do I screen a donor? |
| § 1271.80 - What are the general requirements for donor testing? |
| § 1271.85 - What donor testing is required for different types of cells and tissues? |
| § 1271.90 - Are there other exceptions and what labeling requirements apply? |
| Subpart D - Current Good Tissue Practice |
| § 1271.145 - Prevention of the introduction, transmission, or spread of communicable diseases. |
| § 1271.150 - Current good tissue practice requirements. |
| § 1271.155 - Exemptions and alternatives. |
| § 1271.160 - Establishment and maintenance of a quality program. |
| § 1271.170 - Personnel. |
| § 1271.180 - Procedures. |
| § 1271.190 - Facilities. |
| § 1271.195 - Environmental control and monitoring. |
| § 1271.200 - Equipment. |
| § 1271.210 - Supplies and reagents. |
| § 1271.215 - Recovery. |
| § 1271.220 - Processing and process controls. |
| § 1271.225 - Process changes. |
| § 1271.230 - Process validation. |
| § 1271.250 - Labeling controls. |
| § 1271.260 - Storage. |
| § 1271.265 - Receipt, predistribution shipment, and distribution of an HCT/P. |
| § 1271.270 - Records. |
| § 1271.290 - Tracking. |
| § 1271.320 - Complaint file. |
| Subpart E - Additional Requirements for Establishments Described in § 1271.10 |
| § 1271.330 - Applicability. |
| § 1271.350 - Reporting. |
| § 1271.370 - Labeling. |
| Subpart F - Inspection and Enforcement of Establishments Described in § 1271.10 |
| § 1271.390 - Applicability. |
| § 1271.400 - Inspections. |
| § 1271.420 - HCT/Ps offered for import. |
| § 1271.440 - Orders of retention, recall, destruction, and cessation of manufacturing. |