Title 21

PART 1271

Part 1271 - Human Cells, Tissues, And Cellular And Tissue-based Products

PART 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Authority:42 U.S.C. 216, 243, 263a, 264, 271. Source:66 FR 5466, Jan. 19, 2001, unless otherwise noted.

21:8.0.1.5.60.1SUBPART A
Subpart A - General Provisions
21:8.0.1.5.60.1.1.1SECTION 1271.1
   1271.1 What are the purpose and scope of this part
21:8.0.1.5.60.1.1.2SECTION 1271.3
   1271.3 How does FDA define important terms in this part
21:8.0.1.5.60.1.1.3SECTION 1271.10
   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
21:8.0.1.5.60.1.1.4SECTION 1271.15
   1271.15 Are there any exceptions from the requirements of this part
21:8.0.1.5.60.1.1.5SECTION 1271.20
   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
21:8.0.1.5.60.2SUBPART B
Subpart B - Procedures for Registration and Listing
21:8.0.1.5.60.2.1.1SECTION 1271.21
   1271.21 When do I register, submit an HCT/P list, and submit updates
21:8.0.1.5.60.2.1.2SECTION 1271.22
   1271.22 How do I register and submit an HCT/P list
21:8.0.1.5.60.2.1.3SECTION 1271.23
   1271.23 How is a waiver from the electronic format requirements requested
21:8.0.1.5.60.2.1.4SECTION 1271.25
   1271.25 What information is required for establishment registration and HCT/P listing
21:8.0.1.5.60.2.1.5SECTION 1271.26
   1271.26 When must I amend my establishment registration
21:8.0.1.5.60.2.1.6SECTION 1271.27
   1271.27 Will FDA assign me a registration number
21:8.0.1.5.60.2.1.7SECTION 1271.37
   1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings
21:8.0.1.5.60.3SUBPART C
Subpart C - Donor Eligibility
21:8.0.1.5.60.3.1.1SECTION 1271.45
   1271.45 What requirements does this subpart contain
21:8.0.1.5.60.3.1.2SECTION 1271.47
   1271.47 What procedures must I establish and maintain
21:8.0.1.5.60.3.1.3SECTION 1271.50
   1271.50 How do I determine whether a donor is eligible
21:8.0.1.5.60.3.1.4SECTION 1271.55
   1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain
21:8.0.1.5.60.3.1.5SECTION 1271.60
   1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete
21:8.0.1.5.60.3.1.6SECTION 1271.65
   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
21:8.0.1.5.60.3.1.7SECTION 1271.75
   1271.75 How do I screen a donor
21:8.0.1.5.60.3.1.8SECTION 1271.80
   1271.80 What are the general requirements for donor testing
21:8.0.1.5.60.3.1.9SECTION 1271.85
   1271.85 What donor testing is required for different types of cells and tissues
21:8.0.1.5.60.3.1.10SECTION 1271.90
   1271.90 Are there other exceptions and what labeling requirements apply
21:8.0.1.5.60.4SUBPART D
Subpart D - Current Good Tissue Practice
21:8.0.1.5.60.4.1.1SECTION 1271.145
   1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.
21:8.0.1.5.60.4.1.2SECTION 1271.150
   1271.150 Current good tissue practice requirements.
21:8.0.1.5.60.4.1.3SECTION 1271.155
   1271.155 Exemptions and alternatives.
21:8.0.1.5.60.4.1.4SECTION 1271.160
   1271.160 Establishment and maintenance of a quality program.
21:8.0.1.5.60.4.1.5SECTION 1271.170
   1271.170 Personnel.
21:8.0.1.5.60.4.1.6SECTION 1271.180
   1271.180 Procedures.
21:8.0.1.5.60.4.1.7SECTION 1271.190
   1271.190 Facilities.
21:8.0.1.5.60.4.1.8SECTION 1271.195
   1271.195 Environmental control and monitoring.
21:8.0.1.5.60.4.1.9SECTION 1271.200
   1271.200 Equipment.
21:8.0.1.5.60.4.1.10SECTION 1271.210
   1271.210 Supplies and reagents.
21:8.0.1.5.60.4.1.11SECTION 1271.215
   1271.215 Recovery.
21:8.0.1.5.60.4.1.12SECTION 1271.220
   1271.220 Processing and process controls.
21:8.0.1.5.60.4.1.13SECTION 1271.225
   1271.225 Process changes.
21:8.0.1.5.60.4.1.14SECTION 1271.230
   1271.230 Process validation.
21:8.0.1.5.60.4.1.15SECTION 1271.250
   1271.250 Labeling controls.
21:8.0.1.5.60.4.1.16SECTION 1271.260
   1271.260 Storage.
21:8.0.1.5.60.4.1.17SECTION 1271.265
   1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
21:8.0.1.5.60.4.1.18SECTION 1271.270
   1271.270 Records.
21:8.0.1.5.60.4.1.19SECTION 1271.290
   1271.290 Tracking.
21:8.0.1.5.60.4.1.20SECTION 1271.320
   1271.320 Complaint file.
21:8.0.1.5.60.5SUBPART E
Subpart E - Additional Requirements for Establishments Described in § 1271.10
21:8.0.1.5.60.5.1.1SECTION 1271.330
   1271.330 Applicability.
21:8.0.1.5.60.5.1.2SECTION 1271.350
   1271.350 Reporting.
21:8.0.1.5.60.5.1.3SECTION 1271.370
   1271.370 Labeling.
21:8.0.1.5.60.6SUBPART F
Subpart F - Inspection and Enforcement of Establishments Described in § 1271.10
21:8.0.1.5.60.6.1.1SECTION 1271.390
   1271.390 Applicability.
21:8.0.1.5.60.6.1.2SECTION 1271.400
   1271.400 Inspections.
21:8.0.1.5.60.6.1.3SECTION 1271.420
   1271.420 HCT/Ps offered for import.
21:8.0.1.5.60.6.1.4SECTION 1271.440
   1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.