21 CFR
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? 601 × 483
- § 1271.50 How do I determine whether a donor is eligible? 394 × 483
- § 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? 491 × 483
- § 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete? 60 × 483
- § 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? 82 × 483
- § 1271.75 How do I screen a donor? 474 × 483
- § 1271.80 What are the general requirements for donor testing? 200 × 483
- § 1271.85 What donor testing is required for different types of cells and tissues? 203 × 483
- § 1271.90 Are there other exceptions and what labeling requirements apply? 110 × 483
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 44 × 483
- § 1271.155 Exemptions and alternatives 1 × 483
- § 1271.160 Establishment and maintenance of a quality program 285 × 483
- § 1271.170 Personnel 35 × 483
- § 1271.180 Procedures 237 × 483
- § 1271.190 Facilities 73 × 483
- § 1271.195 Environmental control and monitoring 127 × 483
- § 1271.200 Equipment 158 × 483
- § 1271.210 Supplies and reagents 45 × 483
- § 1271.215 Recovery 6 × 483
- § 1271.220 Processing and process controls 28 × 483
- § 1271.225 Process changes 19 × 483
- § 1271.230 Process validation 101 × 483
- § 1271.250 Labeling controls 25 × 483
- § 1271.260 Storage 248 × 483
- § 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P 261 × 483
- § 1271.270 Records 172 × 483
- § 1271.290 Tracking 58 × 483
- § 1271.320 Complaint file 89 × 483
Subpart E - Additional Requirements for Establishments Described in § 1271.10
- § 1271.330 Applicability
- § 1271.350 Reporting 28 × 483
- § 1271.370 Labeling 7 × 483