Description
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).
Scope & Applicability
Product Classes
1Subject of the guidance document
Stakeholders
1Entities involved in the removal or processing of HCT/Ps.
Regulatory Context
Attributes
1Status of tissue before release for transplantation
Identified Hazards
Hazards
2TSE-associated prions as a contamination risk
Risk to be prevented during tissue processing
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
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See Also (8)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff (Status: Final)
- Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry (Status: Final)
- Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry (Status: Final)
- Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements: Guidance for Industry (Status: Final)
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Status: Final)
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry (Status: Final)