# Sperm and egg cryobank software that ties every vial to the donor eligibility file behind it

> A sperm and egg cryobank is an establishment that recovers, screens, tests, stores and distributes reproductive cells, which the FDA regulates as HCT/Ps under 21 CFR Part 1271. The rules are specific. A donor eligibility determination is required for both the oocyte donor and the semen donor of an embryo, anonymous semen must be quarantined and the donor retested at least 6 months after donation, and records are kept for 10 years. Neurobird holds the donor, the vial and the release decision on one record.

- URL: https://neurobird.com/spermegg/
- Product: Neurobird Sperm Egg Cryobank Compliance Platform
- Niche: sperm egg cryobank
- Buyer: sperm banks, egg banks and fertility laboratories
- Status: in development, open for early access
- Updated: 2026-08-22

## What Neurobird Sperm Egg Cryobank does

- Hold the donor screening, the test results and the eligibility determination as one dated file
- Keep anonymous semen in quarantine until the retest at 6 months is actually complete
- Print the accompanying summary of records with the vial rather than reassembling it later
- Track any unit from the donor to the consignee and from the consignee back to the donor

## How it works

1. **Open the donor** Relevant medical records reviewed for the risk factors the rule names, the specimen collected inside the window the rule allows, and the testing laboratory recorded with its CLIA standing.
2. **Hold and release** Units sit in quarantine, clearly distinguishable from released stock, until a responsible person has documented the eligibility determination and, for anonymous semen, the retest has come back.
3. **Ship with the file** Each container carries its distinct identification code, the eligibility statement and the summary of records, and the tracking entry runs in both directions from the moment it leaves.

## From the source material

> IVF is an ART procedure in which an egg is removed from a mature ovarian follicle and fertilized by a sperm cell outside the body.

Source: womenshealth.va.gov, https://www.womenshealth.va.gov/topics/fertility-services.asp

## Industry context

- **6 months** Minimum interval after the date of donation before a new specimen must be collected from an anonymous semen donor and retested for every agent required at donation, with directed donors excepted. (source: 21 CFR 1271.85, https://www.law.cornell.edu/cfr/text/21/1271.85)
- **10 years** Retention period for records, counted at least 10 years after the date the HCT/P was administered, or after its distribution, disposition or expiration when the administration date is not known. (source: 21 CFR 1271.270, https://www.law.cornell.edu/cfr/text/21/1271.270)
- **7 days** Window around recovery for collecting the donor specimen used in testing, extended to 30 days before recovery for donors of oocytes, peripheral blood stem cells or bone marrow. (source: 21 CFR 1271.80, https://www.law.cornell.edu/cfr/text/21/1271.80)
- **5 agents** Communicable disease agents every donor specimen must be tested for: human immunodeficiency virus type 1, type 2, hepatitis B virus, hepatitis C virus and Treponema pallidum, with chlamydia and gonorrhea added for reproductive donors. (source: 21 CFR 1271.85, https://www.law.cornell.edu/cfr/text/21/1271.85)
- **5 days** Time an establishment has after beginning operations to register with the FDA and submit a list of every HCT/P it manufactures, with the registration updated annually in December. (source: 21 CFR 1271.21, https://www.law.cornell.edu/cfr/text/21/1271.21)
- **1271.290** The tracking section, which requires a system that runs from the donor to the consignee and from the consignee back to the donor, using a distinct identification code that carries no name, social security number or medical record number. (source: 21 CFR 1271.290, https://www.law.cornell.edu/cfr/text/21/1271.290)

## Pricing

- Single laboratory: $249 per month
- Bank: $720 per month
- Network: $1,650 per month

## Questions

### What is a sperm and egg cryobank required to do before releasing a unit?

Screen the donor by reviewing relevant medical records, test a specimen collected inside the window at 21 CFR 1271.80, and have a responsible person document an eligibility determination. Anonymous semen additionally stays in quarantine until the donor is retested at least 6 months after the donation.

### What are the tests every donor has to have?

Under 21 CFR 1271.85 all donors are tested for human immunodeficiency virus types 1 and 2, hepatitis B virus, hepatitis C virus and Treponema pallidum. Donors of reproductive cells are additionally tested for Chlamydia trachomatis and Neisseria gonorrhea unless the recovery method rules out genitourinary contamination.

### How long do the records have to be kept?

At least 10 years, counted from the date the unit was administered. Where the administration date is unknown the clock runs from distribution, disposition or expiration, whichever is latest, so a unit that sits in a tank for years extends its own retention.

### Does this replace our laboratory information system?

No. Testing stays where testing happens. This is the eligibility and release side: which donor a vial belongs to, what state it is in, who signed it out, and what has to accompany it when it ships.

### Can it handle autologous and partner units?

Yes, and it treats them as the rule does. Those units are excepted from the eligibility determination under 21 CFR 1271.90 but still carry mandatory labeling, so the exception is recorded as an exception rather than as a missing file.

## Sources

- [21 CFR 1271.45, donor eligibility requirements](https://www.law.cornell.edu/cfr/text/21/1271.45)
- [21 CFR 1271.85, donor testing by tissue type](https://www.law.cornell.edu/cfr/text/21/1271.85)
- [21 CFR 1271.80, general requirements for donor testing](https://www.law.cornell.edu/cfr/text/21/1271.80)
- [21 CFR 1271.55, records that accompany an HCT/P](https://www.law.cornell.edu/cfr/text/21/1271.55)
- [21 CFR 1271.270, records and length of retention](https://www.law.cornell.edu/cfr/text/21/1271.270)
- [21 CFR 1271.290, tracking](https://www.law.cornell.edu/cfr/text/21/1271.290)

## Contact

- office@neurobird.com
- https://neurobird.com/