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Policies & Protocols

  • Donor Patient Confidentiality
  • Research Protocols
  • Universal Procedures of Interaction
  • Continuous Process Improvement
  • FDA Reference Guide
  • Guidelines for Social Media Sharing
  • Donor Center Manual of Operations
  • Research Repository Critical Facts Sheet
  • Donor Transfers
  • GRID
  1. Donor Centers
  2. Policies & Protocols
  3. FDA Reference Guide

FDA Reference Guide

Regulatory Links

Links to information, regulations and training regarding FDA requirements for NMDP products. 

FDA Approved Test Kit Listing HIV, HTLV, Hepatitis (Donor Screening)

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095440.htm  

Establishment Registration

  • Regulation
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271&showFR=1&subpartNode=21:8.0.1.5.52.2
  • General Information and Links:
    https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration
  • Tools:
    • Establishment Registration: General Information (PDF)
    • Establishment Registration: Electronic Completion of eHCTERS (PDF)
    • International Registry Tool (PDF)

Donor Eligibility Determination

  • Regulation:
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=1271&showFR=1&subpartNode=21:8.0.1.5.52.3
  • Guidance:
    http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf

Good Tissue Practices (GTP's)

  • Regulation:
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271
  • Final Guidance:
    www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM285223.pdf 
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