Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&amp;showFR=1
Timestamp: 2019-04-21 10:13:25+00:00

Document:
§ 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?
§ 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?
§ 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?
§ 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.
§ 1271.195 - Environmental control and monitoring.
§ 1271.210 - Supplies and reagents.
§ 1271.220 - Processing and process controls.
§ 1271.225 - Process changes.
§ 1271.230 - Process validation.
§ 1271.250 - Labeling controls.
§ 1271.265 - Receipt, predistribution shipment, and distribution of an HCT/P.
§ 1271.320 - Complaint file.
§ 1271.420 - HCT/Ps offered for import.
§ 1271.440 - Orders of retention, recall, destruction, and cessation of manufacturing.
Authority: 42 U.S.C. 216, 243, 263a, 264, 271.
Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

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