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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter LPart 1271


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION

PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

rule

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?
rule

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?
rule

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?
rule

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.
rule

Subpart E—ADDITIONAL REQUIREMENTS FOR ESTABLISHMENTS DESCRIBED IN §1271.10

§1271.330
Applicability.
§1271.350
Reporting.
§1271.370
Labeling.
rule

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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