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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance document applies to you, all tissue establishments. We, the Food and Drug Administration (FDA), want to remind you that under current FDA regulations, you must prepare, validate, and follow written procedures to prevent infectious disease contamination or cross-contamination (both subsequently referred to as "contamination") during tissue processing (21 CFR 1270.31(d)). Contamination may be caused by a variety of infectious disease agents including viruses, bacteria, fungi, and transmissible spongiform encephalopathy (TSE)- associated prions. The regulations concerning human tissue intended for transplantation are found in 21 CFR parts 1270 and 1271. Relevant portions of the regulation state that: · "Processing means any activity performed on tissue, other than tissue recovery, including preparation, preservation for storage, and/or removal from storage to assure the quality and/or sterility of human tissue. Processing includes steps to inactivate and remove adventitious agents." 21 CFR 1270.3(p). · "There shall be written procedures prepared, validated, and followed for prevention of infectious disease contamination or cross-contamination by tissue during processing." 21 CFR 1270.31(d). · "[A]ny facility may use current standard written procedures such as those in a technical manual prepared by another organization, provided the procedures are consistent with and at least as stringent as the requirements of this part." 21 CFR 1270.31(e).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 02D-0073.