Standard: HHS - 21 CFR PART 1270

HUMAN TISSUE INTENDED FOR TRANSPLANTATION

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Scope:

(a) The regulations in this part apply to human tissue and to establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue.

(b) Regulations in this chapter as they apply to drugs, biologics, devices, or other FDA-regulated commodities do not apply to human tissue, except as specified in this part.

(c) Regulations in this chapter do not apply to autologous human tissue.

(d) Regulations in this chapter do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 1270
Publish Date: 2016-04-01
Page Count: 6
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 1270 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV
21 CFR PART 1270 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV

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