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)
- Watermarked AID-00084 Establishment Registration: General Information (Legacy A00455) - effective July 29, 2024
- 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