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:
• AID-00084 Establishment Registration: General Information (Legacy A00455)
• AID-00085 Establishment Registration: Electronic Completion of eHCTERS (Legacy A00456)
• 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