Donor eligibility backed by ex-FDA TRG reviewers.
Donor eligibility, from intake to inspection.
Quick and easy access to assessments you can trust.
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Clear a donor in minutes.
Upload the screening, testing, and records you have for one donor and get back a structured determination — a clear outcome and the specific gaps that need to close.
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Reviewed based on FDA expectations.
Every eligibility determination is reviewed against FDA expectations to ensure it stands up to regulator inspections.
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Establishment-level inspection ready.
Pre-audit your establishment program controls including screening, testing, records and SOPs against audit expectations.
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Catch false positives.
When evidence is missing or ambiguous, the assessment flags it rather than passing it — built to err on the side of caution, because a false “eligible” is the costliest error in donor eligibility.
Scott A. Brubaker
Nearly 40 years in human tissue policy. Scott chaired CBER’s Tissue Reference Group and served nearly 8 years as Director of FDA’s Division of Human Tissues, leading federal policy under 21 CFR Part 1271 — after 12 years as SVP of Policy at the AATB.
Special Advisor at Deffai · author of the Standards for Tissue Banking (AATB, editions 11–14).
More ways we help HCT/P teams.
TRG Submission
Confirm whether your HCT/P is regulated under Section 361 or 351 — framed the way FDA expects to see it.
FDA Resources
Playbooks and explainers on Part 1271, the Tissue Reference Group, and HCT/P classification.
Pricing
Fixed price, quoted upfront — based on your program. No hourly billing, no surprises.
Frequently asked
Does Deffai make the eligibility determination for us?
We provide draft report and determination rationale. The determination of record is made and signed by your establishment’s Responsible Person under your validated SOPs.
Does this cover both 361 and 351 products?
Yes. Donor eligibility under 21 CFR Part 1271 Subpart C applies to both 361 HCT/Ps and 351 HCT/Ps.
What do we upload, and what do we get back?
You provide the records you have for one donor — screening, testing, and documentation. You get back a structured Donor Eligibility Determination Report, with every finding cited to the governing section, that you can export to Word.
Who is this built for?
HCT/P recovery and processing establishments, tissue banks, and the Responsible Persons and QA / regulatory teams accountable for every determination.
Who built it?
Former FDA reviewers — including the former Director of FDA’s Division of Human Tissues, who chaired CBER’s Tissue Reference Group, and a former TRG reviewer.
Do you use our data to train AI?
No. We never train AI on your data, and we don’t allow third parties, including foundation models, to either. Read more about security.