21 CFR Part 1271
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
- PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
- 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
- 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.
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