# 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. - URL: https://neurobird.com/tissuebank/ - Product: Neurobird Tissue Bank Revenue Recovery Platform - Niche: tissue bank - Buyer: tissue banks and recovery agencies - Status: in development, open for early access - Updated: 2026-08-21 ## What Neurobird Tissue Bank does - 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 - Report adverse reactions within the 15 calendar day window without hunting for the file ## How it works 1. **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. 2. **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. 3. **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. ## From the source material > The PTSD Brain Bank is a human tissue bank that collects, processes, stores and gives out research specimens for future scientific studies. Source: research.va.gov, https://www.research.va.gov/programs/tissue_banking/PTSD/ ## Industry context - **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. (source: eCFR, 21 CFR Part 1271, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/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. (source: eCFR, 21 CFR 1271.21, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-B/section-1271.21) - **10 years** Records must be retained for 10 years after administration, distribution, disposition or expiration, whichever is latest, under 21 CFR 1271.270. (source: eCFR, 21 CFR 1271.270, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-D/section-1271.270) - **15 days** Adverse reaction reports must reach FDA within 15 calendar days of initial receipt of the information, under 21 CFR 1271.350. (source: eCFR, 21 CFR 1271.350, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-E/section-1271.350) - **4 criteria** All 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. (source: eCFR, 21 CFR 1271.10, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-A/section-1271.10) ## Pricing - Single site: $420 per establishment, per month - Processor: $950 per establishment, per month - Multi site network: $1,800 per establishment, per month ## Questions ### 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. ## Sources - [21 CFR Part 1271, human cells and tissues](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271) - [21 CFR Part 1271 subpart C, donor eligibility](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-C) - [21 CFR Part 1271 subpart D, current good tissue practice](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-D) - [FDA, tissue establishment registration](https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) ## Contact - office@neurobird.com - https://neurobird.com/