Tissue bank software built around the 21 CFR 1271 record you will be asked for
A tissue bank is an establishment that recovers, screens, processes, stores or distributes human cells, tissues and cellular and tissue based products, known as HCT/Ps. In the United States these establishments are regulated by FDA under 21 CFR Part 1271: registration within 5 days of beginning operations, donor eligibility under subpart C, current good tissue practice under subpart D, and records held for 10 years. Neurobird keeps the donor to graft chain intact so the eligibility determination travels with every unit.
Neurobird Tissue Bank in short
- Hold donor screening, physical assessment and testing results as one eligibility determination under 21 CFR 1271 subpart C
- Track recovery, processing and packaging as lots, with every graft tied back to its donor
- Keep core CGTP records under subpart D so an inspector can be shown rather than told
- 1271 21 CFR Part 1271 is the single federal rule governing human cells, tissues and cellular and tissue based products, covering registration, donor eligibility, good tissue practice and reporting. eCFR, 21 CFR Part 1271
- 5 days An HCT/P establishment must register with FDA within 5 days of beginning operations and submit a listing of each product it handles, under 21 CFR 1271.21. eCFR, 21 CFR 1271.21
- Pricing runs 420 to 1800 US dollars per month across 3 tiers. Early access is free.
What tissue banks and recovery agencies actually deal with
Why it stays broken
The regulation is written per donor and per lot, and the software most banks use is written per shipment. So the eligibility determination, the serology panel and the processing record live in 3 separate systems and get stapled together by hand at inspection time.
One donor can yield dozens of grafts across several lots, and every one of them has to point back.
The PTSD Brain Bank is a human tissue bank that collects, processes, stores and gives out research specimens for future scientific studies.
Neurobird Tissue Bank Revenue Recovery Platform
Make the donor eligibility determination the root record, then hang recovery, processing lots, release and distribution off it. Traceability stops being a reconstruction job.
- 1Hold donor screening, physical assessment and testing results as one eligibility determination under 21 CFR 1271 subpart C
- 2Track recovery, processing and packaging as lots, with every graft tied back to its donor
- 3Keep core CGTP records under subpart D so an inspector can be shown rather than told
- 4Report adverse reactions within the 15 calendar day window without hunting for the file
What changes with Neurobird Tissue Bank?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird Tissue Bank |
|---|---|
| Donor eligibility depends on a screening record, a physical assessment and a testing panel that arrive at different times from different people | Hold donor screening, physical assessment and testing results as one eligibility determination under 21 CFR 1271 subpart C |
| One donor becomes many grafts across several lots, and the link back from a distributed graft to its donor has to survive 10 years of records retention | Track recovery, processing and packaging as lots, with every graft tied back to its donor |
| An FDA inspection asks for the eligibility determination and the CGTP records for a specific lot, and pulling them takes days | Keep core CGTP records under subpart D so an inspector can be shown rather than told |
Who is this for?
Same regulation, three different establishment types.
You recover and hand off
Your eligibility determination follows the tissue to a processor. It has to arrive complete, because their release decision depends on it.
You process and release
Lot genealogy is your exposure. You need every distributed graft to resolve back to a donor in one step, for 10 years.
You run several registered sites
Each site registers separately and gets inspected separately. You need one record standard across all of them, not per site habits.
How human tissue is actually regulated
Useful if you are standing up an establishment or preparing for inspection. Each source links out.
21 CFR Part 1271 is the single federal rule governing human cells, tissues and cellular and tissue based products, covering registration, donor eligibility, good tissue practice and reporting.
eCFR, 21 CFR Part 1271An HCT/P establishment must register with FDA within 5 days of beginning operations and submit a listing of each product it handles, under 21 CFR 1271.21.
eCFR, 21 CFR 1271.21Records must be retained for 10 years after administration, distribution, disposition or expiration, whichever is latest, under 21 CFR 1271.270.
eCFR, 21 CFR 1271.270Adverse reaction reports must reach FDA within 15 calendar days of initial receipt of the information, under 21 CFR 1271.350.
eCFR, 21 CFR 1271.350All 4 criteria in 21 CFR 1271.10 must be met for a product to be regulated solely under section 361: minimally manipulated, homologous use, not combined, and no systemic effect.
eCFR, 21 CFR 1271.10The donor to graft chain, as your bank would run it
A working preview. Tick a step to move the donor record forward.
| Line item | Amount | |
|---|---|---|
| Recovery to processing, 14 hours | $1,840 | |
| Distribution, 12 grafts released | $620 | |
| Aseptic processing lot 88-C | $3,275 | |
| Donor 2026-0418, eligibility determination | $455 |
Click recover to add a missed line to the invoice.
How does Neurobird Tissue Bank work?
Build the eligibility determination
Screening record, physical assessment and relevant communicable disease testing resolve to one determination under 21 CFR 1271 subpart C, with the responsible person recorded.
Keep lot genealogy
Recovery to processing to packaging is tracked as lots. Every distributed graft resolves back to its donor in one step, not by cross referencing spreadsheets.
Hold the CGTP record
Core subpart D records sit with the lot they belong to, and 10 year retention under 1271.270 is the default rather than an archiving project.
Tissue bank software questions, answered
Key terms
- What is a tissue bank?
- A tissue bank is an establishment that recovers, screens, processes, stores or distributes human cells, tissues and cellular and tissue based products, known as HCT/Ps. In the United States these establishments are regulated by FDA under 21 CFR Part 1271, which covers registration, donor eligibility, current good tissue practice and adverse reaction reporting.
- What does 21 CFR Part 1271 actually require?
- Registration and product listing under subpart B, donor eligibility determination under subpart C, current good tissue practice under subpart D, and adverse reaction reporting under subpart E. An establishment must register within 5 days of beginning operations and list each HCT/P it handles.
- What is a 361 HCT/P?
- A product regulated solely under section 361 of the Public Health Service Act, which needs no premarket approval. To qualify it must meet all the criteria in 21 CFR 1271.10: minimally manipulated, intended for homologous use, not combined with another article, and with no systemic effect or dependence on living cell metabolic activity. Anything outside that is regulated as a drug, device or biological product.
How long do tissue records have to be kept?
Under 21 CFR 1271.270, records must be retained for 10 years after the date of administration, distribution, disposition or expiration, whichever is latest. That is why the donor to graft link has to be durable rather than reconstructed.
Does this replace our processing equipment records?
No. It holds the donor eligibility determination, the lot genealogy, the release decision and the distribution record. Equipment and environmental monitoring data can be attached to the lot it belongs to.
Why we are building this
Tissue banking is one of the few fields where the regulation is clearer than the software. 21 CFR Part 1271 tells you exactly what the record has to contain and how long to keep it. Most banks still assemble that record from a paper file, a lab system and a spreadsheet.
The cost shows up at inspection, when an eligibility determination and its CGTP records take days to pull for a lot that shipped 4 years ago.
We would rather build this with people who have sat through an FDA inspection. Tell us how your records actually work, and where we have got it wrong.
Where the requirement comes from
The federal rule and the FDA guidance that define the obligation.
- 21 CFR Part 1271, human cells and tissues The full rule: registration, donor eligibility, good tissue practice, labelling and reporting.
- 21 CFR Part 1271 subpart C, donor eligibility Screening, physical assessment and testing requirements behind the eligibility determination.
- 21 CFR Part 1271 subpart D, current good tissue practice Core CGTP requirements including facilities, process controls, labelling controls and records.
- FDA, tissue establishment registration How establishments register and list HCT/Ps, and where the public registration data sits.
How much does Neurobird Tissue Bank cost?
Priced per establishment because registration and inspection are per establishment. Donors, lots and users are unlimited on every tier.
- Donor eligibility records
- Recovery logging
- Lot genealogy
- Distribution records
- Email support
- Everything in Single site
- CGTP subpart D record set
- Release decision workflow
- Adverse reaction reporting in 15 days
- Named contact
- Everything in Processor
- Recovery agency to processor handoff
- Inspection readiness export
- 10 year retention archive
- Onboarding included
Get free early access
If you run a tissue bank, tell us how donor eligibility and lot genealogy are recorded today.
Straight answer on where this is: In development. Early access gets the working preview, a say in what ships first, and early access pricing. It does not get you a login today.
Prefer email? Write to office@neurobird.com and a person will reply. No autoresponder.