Cryopreservation of reproductive tissue – including sperm, epididymal/vasal aspirates, and testicular tissue – offers hope for fertility preservation and donor conception. However, it also raises critical infectious disease safety challenges. Both New York State (NYS) and the U.S. Food and Drug Administration (FDA) enforce strict regulations to protect recipients (and any future offspring) from disease transmission.
In this article, we’ll clarify what it means for a donor/specimen to be “eligible” or “ineligible” per FDA definitions, outline FDA donor eligibility requirements (and how determinations are made), and review specific issues considered during screening. We also include a comparison table of FDA and NYS requirements for various donor types. Our aim is to balance technical accuracy with approachable language – empowering readers with knowledge while acknowledging the personal stakes involved.
Regulatory Oversight of Cryopreserved Reproductive Tissues
In the United States, reproductive cell/tissue banking is regulated by multiple authorities. At the federal level, donated sperm and eggs are classified as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under FDA rules[1][2]. The FDA’s regulations (21 CFR Part 1271) set nationwide donor eligibility standards – requiring screening for risk factors and testing of donor samples for specific infectious diseases[3]. Any facility involved in recovering, processing, storing, or distributing reproductive tissues must register with the FDA and comply with these standards[4]. FDA inspectors also audit tissue banks for compliance[5].
New York State, known for having some of the most robust tissue bank regulations, adds an extra layer of requirements. The NYS Department of Health mandates that tissue banks and fertility clinics operating in New York be licensed and adhere to state-specific rules (10 NYCRR Part 52, Subpart 52-8) for reproductive tissues. These include all the federal requirements plus additional provisions (such as genetic screening in certain cases)[6][7]. Importantly, NYS law explicitly defines donor categories – anonymous donors, directed donors, and client-depositors – and ties specific rules to each[8]. Any reproductive tissue (sperm, eggs, embryos) used in New York for someone other than the provider or their intimate partner must meet NYS’s screening and testing standards[9][10]. Facilities in NYS can only use donor tissues from banks licensed by the NY DOH’s Tissue Resources Program[11], ensuring state oversight at every step.
Internationally, similar protections exist. For example, in the UK, clinics licensed by the HFEA (Human Fertilisation & Embryology Authority) must perform rigorous donor health tests and typically quarantine donor sperm for 6 months[12]. The European Union directives likewise require HIV, hepatitis, syphilis testing and a 180-day quarantine for sperm donors, though they allow use of advanced nucleic acid testing (NAT) to potentially bypass the full quarantine period[12]. (EU guidance suggests that if sensitive NAT screening is used for HIV, HBV, and HCV, the 180-day storage and re-test may not be necessary[13] – a contrast to the U.S., where FDA rules still mandate quarantine and retesting for anonymous donors.) In Canada, the “Safety of Sperm and Ova Regulations” similarly impose donor screening, infectious disease testing, and quarantine of donor gametes until the donor is deemed suitable[14]. Throughout the world, the consensus is clear: protecting recipients from infection is paramount, even if it means added steps and waiting periods in the cryopreservation process.
Donor Categories: Client Depositors vs. Directed vs. Anonymous Donors
Understanding the terminology of donor categories is crucial, as regulations differ based on who the tissue came from and who it is intended for:
- Client-Depositor (Autologous Patient): This refers to an individual who banks their own reproductive tissue for personal future use (or use by their regular sexual partner)[15][16]. For example, a man freezing sperm prior to cancer therapy for use with his wife later, or a person storing eggs for their future attempt at pregnancy. In the eyes of regulators, this is not an “allogeneic” donation since the tissue will be used by the same person (or their intimate partner). NYS defines a client-depositor as someone who deposits reproductive tissue for use solely on themselves or their regular partner[16]. Such autologous cases are generally exempt from the strict donor-eligibility requirements applied to donors for third-party use. In FDA terms, a “donor eligibility determination” is not required for autologous cells[17][18]. Likewise, NYS does not consider a client-depositor to be a “donor” under its donor definitions (since they are not donating to someone else)[19]. This means many of the infectious disease testing rules that apply to donors may not apply if you are simply storing your own sperm/eggs for your own later use. (However, as we’ll discuss, if that same person later decides to direct their banked sample to someone else – e.g. donating leftover sperm or embryos to another individual – then full donor testing must be done at that time.) Please note that each reproductive tissue bank may impose rules that are more restrictive then local. State or Federal Regulations….they just need to meet or exceed regulatory requirements.
- Directed Donor: A directed donor is someone who donates reproductive tissue to a specific, known recipient (other than a spouse/intimate partner). For example, a sister might donate her eggs to her sibling, or a male friend donates sperm to a woman he knows. In NYS law, a directed donor is defined as a donor “who is known to the recipient and who directs his or her reproductive tissue for use by a particular recipient,” including cases like “a man providing semen to a surrogate who is not his regular sexual partner.”[20] In other words, if the donor and recipient know each other and the donor designates their sample for that person, it’s a directed donation. Directed donors are subject to screening and testing requirements much like anonymous donors – because the tissue is going into someone other than the donor or their intimate partner[21]. Both FDA and NYS require a full donor eligibility workup for directed donors, with one key difference: if a directed donor is found to have a risk factor or even tests positive for a disease, there is an option to still use the sample under certain conditions (with appropriate warnings, consent, and documentation)[22][23]. We will explain this exception later. Also, directed donations require a six-month quarantine of semen in the same way anonymous donations do with some exceptions (NYS allows a waiver of quarantine with informed consent in directed cases)[24][25]. Essentially, directed donors are treated with the same rigorous testing as anonymous donors, but the regulations provide some flexibility if the known recipient is willing to accept certain risks.
- Anonymous Donor: An anonymous donor is one who donates sperm, eggs, or embryos to the general pool for use by an unknown recipient. The donor’s identity is not known to the recipient, and vice versa[26]. These are typical sperm bank donors or egg donors where recipients select from a catalog but don’t personally know the donor. Because the tissue will be used in strangers, the standards here are the strictest. All infectious disease screening and testing requirements applyfully to anonymous donors under both FDA and state rules[21]. If an anonymous donor has disqualifying risk factors or any positive test for a relevant infection, they cannot be accepted – period[27][28]. Anonymous donations of semen must be frozen and quarantined for at least 180 days, and the donor must be retested (and clear) after that quarantine before the sample can be released for use[24][29]. We can think of anonymous donors as having the highest bar for eligibility since neither the donor nor recipient can personally weigh in on the risks – the regulations step in to ensure maximum safety.
It’s worth noting a fourth category recognized in FDA rules: sexually intimate partner donations. If reproductive cells are donated by a “sexually intimate partner of the recipient for reproductive use,” the FDA completely exempts those from the donor eligibility requirements[30][31]. In simpler terms, when a couple is already sexually intimate (e.g. a husband providing sperm for his wife’s IVF, or a cohabiting couple donating eggs/sperm to create embryos for themselves), the FDA does not require the formal screening/testing process on that “donation.” The logic is that the partners have already shared potential exposures through natural intimacy. New York’s definitions echo this: a man providing semen to his ownpartner is not a “donor” in the regulatory sense[20]. Thus, partner-only reproductive use is treated as a private matter – though many clinics still may require testing to couples as a good practice (for example, a fertility clinic may test the husband for HIV, hepatitis, etc., to guide safe handling of specimens or inform the couple, even if not mandated). But legally, those partner donations are not held to the same requirements as directed or anonymous donor scenarios.
Summary of donor types: If you bank your own sperm/eggs for yourself (client depositor/autologous), the stringent donor rules don’t immediately apply – unless you later decide to donate those to someone else. If you donate to a specific person you know (directed), all the screening and testing must be done, but you have the option (with proper precautions) to use the sample even if something is flagged. If you donate to unknown recipients (anonymous), you must meet every requirement strictly; any positive infectious marker or high-risk behavior will render you ineligible to donate for use in others. Table 1 below provides a visual comparison of requirements by donor type, for both FDA and New York State:
| Donor Type | Example | Requires Full Infectious Disease Testing? | Quarantine & Retest Required? | Use of “Ineligible” Sample Allowed? | Regulatory Notes |
| Client-Depositor(Autologous) | Man freezing his own sperm for future self-use (or use with spouse). | Not required by FDA/NYS(exempt from donor eligibility)[17][19]. Many clinics still test for lab safety. | No (sample used only by self/partner, no mandated quarantine). | N/A (donor’s own tissue – infectious status only affects handling, not usage by self). | Must be labeled “For Autologous Use Only” if untested[18]. If later directed to others, must do full testing & 6-mo storage then[32]. |
| Directed Donor(Known non-partner) | Friend donating sperm to a single woman; sister donating eggs to sister; intended parents providing gametes to a surrogate. | Yes – same panel as anonymous donors (HIV, HBV, HCV, syphilis, etc.) required[21]. FDA requires eligibility determination each time[33]. | No (NYS allows waiver of 6-mo quarantine with informed consent and frequent testing)[24][25]. FDA does not require quarantine for directed use[34]. | Yes, with proper labeling & consent.FDA: use of an ineligible directed donation “is not prohibited (with proper labeling)”[22]. NYS: would require documented informed consent for high-risk directed use[35]. | Labeling: Must label ineligible directed units with “Biohazard” symbol & disease risk warnings[36]. No retesting required by FDA[34]. Recipient (and doctor) must be notified of test results and must accept the risks. |
| Anonymous Donor | Sperm bank donor for unknown recipients; egg donor donating to general pool. | Yes – full infectious disease panel required by FDA & NYS before acceptance[3]. Ongoing testing every 6 months during active donations[37]. | Yes – semen must be frozen & quarantined 180 days, then donor retested before release[24]. (No quarantine for egg donors, but testing near retrieval and follow-up is required[38].) | No. If an anonymous donor is deemed ineligible (due to test results or risk factors), their tissue cannot be used for reproductive purposes[28]. The sample must be destroyed or used only for approved research[39]. | If any required test is repeatedly positive/reactive, the donor is deferred/excluded[40]. Labeling: Ineligible anonymous HCT/Ps generally may not be distributed[28] (except in rare emergency need cases). Quarantine and retest are mandatory for semen[29]. |
Table 1: Comparison of Requirements for Client-Depositors vs. Directed vs. Anonymous Donors (male reproductive tissue focus). FDA and New York State rules are largely aligned, with NYS explicitly codifying these categories. “Ineligible” refers to a donor who does not pass screening/testing – use of such samples is permitted only in directed or autologous contexts, with strict safeguards.[22][23]
Infectious Disease Screening: What Tests Are Required?
Whether you are a directed or anonymous donor (or a client-depositor who later wants to donate to others), you will undergo a battery of infectious disease tests on your blood (and in some cases urine or swabs). These tests are designed to detect “relevant communicable disease agents and diseases” (RCDADs) – pathogens that could be transmitted through sperm, eggs, or tissue. Both FDA regulations and New York State rules specify essentially the same core panel of tests, which include:
- HIV-1 and HIV-2: All donors are tested for Human Immunodeficiency Virus types 1 and 2, typically via an FDA-approved antibody screening test[41]. (Many labs now use combined antigen/antibody tests or even nucleic acid tests for HIV to narrow the window period.) A positive test for HIV is disqualifying for anonymous donation – the donor is labeled ineligible and the sample cannot be used for a third-party[40]. For directed donations, an HIV-positive donor’s sample could only be used with full disclosure, special labeling (“WARNING: Reactive test results for HIV”), and likely under IRB-approved protocols or specific clinic policies[36]. Notably, New York State law mandates that any semen from a donor who tests repeatedly reactive for HIV-1 or HIV-2 antibodies must be destroyed(unless used in approved research)[42]. There is also a duty in NYS for the sperm bank medical director to notify the Department of Health and any recipient’s physicians if a donor is later found HIV-positive after prior donations[43]. These measures underscore how seriously HIV risk is taken in reproductive tissue banking. (We will discuss later the policies regarding donors with HIV risk factors – e.g. men who have sex with men – under the screening section.)
- Hepatitis B Virus (HBV): Donors are tested for markers of hepatitis B infection. Both HBsAg (Hepatitis B surface antigen) and anti-HBc (antibody to Hepatitis B core antigen) are required tests[44]. A positive HBsAg indicates an active Hep B infection and is an immediate rule-out for donor eligibility[40]. Anti-HBc positivity (which can indicate a past HBV infection) is also cause for exclusion – in fact NYS specifies that anti-HBc must be negative for donor acceptance[45]. FDA guidance similarly notes that if the donor has a positive Hepatitis B core antibody along with any other HBV marker, the donor is ineligible[46]. The only case that might be allowed is if a donor had a positive hepatitis B surface antibody (indicating vaccination or past resolved infection) but negative HBsAg and negative core antibody – that pattern suggests immunity from vaccine, which is acceptable[47]. Practically, donors with any hint of HBV exposure are not used for anonymous donation. Directed use would require extensive counseling – and even then, using an HBV carrier’s sperm/eggs is very rarely done (especially given availability of vaccination for recipients and newborns). Regulations also require a follow-up re-test for Hepatitis B: for anonymous semen donors, after the 6-month quarantine, the donor must be retested for HBsAg and** anti-HBc to ensure he didn’t seroconvert after the initial draw[24]. Only if those remain negative can the frozen semen be released.
- Hepatitis C Virus (HCV): All donors are tested for HCV antibody (anti-HCV)[48]. A reactive HCV test makes the donor ineligible to donate to others[40]. As with HBV, anonymous donors are retested after 6 months in quarantine to rule out window-period infection (anti-HCV should remain negative)[24]. Some banks or programs may also employ HCV NAT (nucleic acid testing) to detect acute infections earlier, though the FDA requirement is an antibody test. Any sample from a donor later found to have HCV antibodies must be discarded or labeled for research use only[39]. Hepatitis C, being blood-borne, could potentially be transmitted via sperm (there have been rare cases of HCV in IVF transmission reported), so strict screening is warranted.
- Syphilis: Donors are tested for Treponema pallidum (syphilis), usually with an RPR (rapid plasma reagin) or similar non-treponemal test, followed by a confirmatory treponemal-specific test if positive. A positive syphilis test initially will defer a donor; however, if the confirmatory test is negative, it may be deemed a false positive and the donor can be accepted[49]. In other words, a reactive screening test for syphilis does not automatically ban use if further testing shows no active infection[50]. But a confirmed syphilis infection (even if treated) is generally disqualifying for anonymous donation. Many programs require evidence of treatment and a long deferral period before a previously positive donor could even be reconsidered. Notably, the EU regulations allow that a non-specific (e.g. RPR) reactive result can be overridden by a non-reactive treponemal confirmatory test[51]. U.S. rules don’t explicitly state this nuance, but in practice the same approach is taken. Syphilis is a treatable disease; a directed donor with a history of syphilis might be allowed if documentation of adequate treatment is provided and current tests are negative – with recipient informed. However, anonymous donor programs will simply exclude anyone with a history of syphilis or positive serology.
- Chlamydia and Gonorrhea: Because these are sexually transmitted infections that can be present in genital fluids, the FDA and NYS require donors of reproductive cells to be tested for Chlamydia trachomatis and Neisseria gonorrhoeae[52]. Typically, a NAAT (nucleic acid amplification test) is performed on urine or a swab (for male donors, often a urine NAAT for both chlamydia and gonorrhea is done)[53]. NYS regulation specifically calls for testing semen or a urethral specimen for gonorrhea, and urine or urethral specimen for chlamydia by a sensitive method[53]. If a donor tests positive for either, they cannot donate unless/until treated and cleared – NYS outright prohibits use of any semen from a donor whose specimen tests positive for gonorrhea or chlamydia[54]. In practice, donor programs will often treat and defer the individual, then retest to see if they become negative (for directed donors, a physician might allow re-entry after successful treatment; for anonymous, many banks would disqualify to be safe). The FDA regulations note that reproductive donors must be tested for these genitourinary infections unless the recovery method bypasses contamination risk[55]. For example, if sperm were surgically retrieved directly from the testicle (testicular sperm extraction), theoretically one might argue chlamydia/gonorrhea in the urethra is irrelevant. Even so, guidelines lean towards testing all donors anyway, since organisms could potentially ascend or a man could have an occult infection in the tract. In summary: a clean STI panelis expected of all donors. Chlamydia and gonorrhea are common in the population, so many sperm banks test donors frequently (e.g. every 3-6 months while donating) to catch any new infection early[37].
- Human T-Lymphotropic Virus (HTLV) Type I/II: HTLV-I and II are retroviruses that can be transmitted through blood, breastfeeding, sexual contact, and possibly tissue transfer. The FDA requires HTLV-I/II antibody testing for certain donors – specifically, it is required for donors of “viable, leukocyte-rich cells or tissues”[56]. Semen is considered a leukocyte-rich tissue (since it contains white blood cells), so sperm donors must be tested for HTLV-I/II[57]. Egg donors (oocyte donors) are not explicitly required to have HTLV testing under FDA rules unless they have risk factors, because eggs have far fewer lymphocytes. But some clinics do test egg donors for HTLV as a precaution, especially if they have risk factors or are from areas with higher HTLV prevalence. New York’s regulations specifically list HTLV-I testing for semen donors[58] (interestingly, NYS only mentioned Type I in the text, but in practice an HTLV-I/II combined test is used). A reactive HTLV test would typically exclude an anonymous donor. The EU, for comparison, only mandates HTLV testing for donors from high-incidence areas or with risk factors[59]. In the U.S., it’s blanket-required for sperm donors. If a donor tests positive or repeatedly reactive for HTLV, they would be deemed ineligible to donate. Since HTLV can cause leukemia/lymphoma and neurologic disorders and has no cure, tissue banks won’t risk that transmission. A directed donor who is HTLV-positive could technically proceed under the “ineligible directed donor” exception if the recipient is informed – but this would be a very serious risk to take. It’s rarely, if ever, done.
- Cytomegalovirus (CMV): CMV is a common virus (related to herpesvirus family) that most adults have been exposed to. It can be transmitted via body fluids including semen. While CMV is not one of the FDA’s officially listed “relevant communicable diseases” for donor eligibility (because a positive CMV IgG does not make a donor ineligible in the same way HIV or hepatitis does), testing is still required for donors of viable leukocyte-rich tissues like semen[60]. The FDA explicitly states that establishments “are required to test donors of viable, leukocyte-rich cells or tissues for CMV”[61]. So sperm donors must have a CMV blood test (typically an IgG/IgM antibody screen)[57]. If a donor tests positive for CMV antibodies, they are not necessarily deferred – they can still be an eligible donor because many people have latent CMV. Instead, the policy is often to inform recipients and possibly to match accordingly. For example, a sperm bank will report whether a donor is CMV IgG positive (past infection) or negative, and physicians may prefer CMV-negative donors for a recipient who has never had CMV (to avoid giving her a primary CMV infection during pregnancy). If a donor’s CMV IgM is positive (suggesting a recent active infection), the bank would defer the donor until the active phase passes. New York’s regs do not list CMV in the required panel explicitly, but in practice NY sperm banks also test for it (and many will not release a CMV IgM-positive donor’s samples until cleared). In summary, CMV testing is done, but a positive IgG doesn’t eliminate a donor; it just requires that the sample is labeled and handled appropriately[61][62]. The FDA requires that a positive CMV result be noted, but the donor can still be “eligible” as long as other tests are fine. Most clinics will have the OB/GYN of the recipient acknowledge the CMV status when selecting donor sperm.
In addition to these tests, New York State uniquely requires a couple of extra lab items for sperm donors: an ABO and Rh blood grouping[63] (to record blood type) and a thorough semen analysis for quality including post-thaw survival[64]. The blood typing doesn’t impact donor eligibility per se, but is recorded in case it’s needed for any reason (and possibly to inform matching or future child’s blood type considerations). The semen analysis ensures the sample meets minimum quality standards for use.
All required infectious disease tests must be done by properly certified labs (CLIA-approved, etc.), and for NYS licensed banks, if the testing is done in New York it must be by a lab with a NYSDOH permit[65] (out-of-state labs must be equivalent). Donors are typically retested at least every 6 months if they continue donating over time, or sooner if any new risks emerge[37]. In practice, active semen donors often get a testing panel every 3-6 months.
It’s important to highlight the timing of these tests relative to donation: The FDA requires that the donor’s blood samples for infectious disease testing be collected within 7 days of the cell/tissue recovery (for living donors) to be valid[66]. For sperm donation, some banks draw blood on the same day as each donation, or at least once a week for frequent donors, to ensure coverage. FDA guidance allows an alternative for directed donors: instead of retesting within 7 days for each donation, they can collect samples for testing periodically (e.g. monthly) as long as quarantine and retest is done like with anonymous donors[67][68]. New York’s waiver for directed donors skipping quarantine requires that all the infectious disease tests be done at most one month before the first donation and then every 3 months during the donation period[25]. This effectively increases the chance of catching a seroconversion closer to real time if the sample is used without the full 6-month quarantine.
Finally, beyond lab tests, donor eligibility involves a screening interview and physical exam to check for symptoms or risk factors of infection[2]. This is just as important as the blood tests, because some diseases can’t be fully tested (e.g. new variants, prions) and some behaviors might indicate risk despite current negative tests.
Donor Screening for Risk Factors and Eligibility Determination
Laboratory tests are only part of the safety net. Equally vital is the donor screening process – an in-depth questionnaire, interview, and exam to uncover any risk factors or medical history that could make a donor unsafe. FDA regulations (21 CFR §1271.75) outline required screening for “relevant communicable disease risk” via the donor’s medical records, social history, and a physical exam[2]. New York State’s rules (Subpart 52-8.5) similarly mandate that reproductive tissue banks “initially screen and periodically assess donors for conditions that may adversely affect…the recipient’s or offspring’s health.”[69]. Here are some key risk factors and screening criteria considered:
- High-Risk Behaviors for HIV, HBV, HCV: Both FDA and NYS incorporate U.S. Public Health Service (USPHS) guidelines on HIV risk. Historically, this included deferring any man who had sex with another man (MSM) in the past 5 years[70] (FDA’s earlier guidance) or 12 months (updated blood donor criteria), anyone who injected illicit drugs, those who had sex in exchange for money or drugs, etc. NYS explicitly says persons with HIV risk factors as identified by USPHS must not be accepted as anonymous donors[71][72]. For directed donors, NYS allows some discretion: risk factors (other than HIV) need not automatically exclude a donor if the medical director determines the risk can be counseled and managed[71]. In practice, if a directed donor has a history such as a new tattoo, a recent travel to a malarial region, or multiple sexual partners, the clinic might still proceed but only with thorough informed consent of the recipient. However, for anonymous donors, any such risk is a straight “no.” For example, NYS 52-8.5 specifically lists as exclusionary: having more than one sexual partner in the last 6 months, a history of STDs, prior exclusion from blood donation for infectious reasons, recent transfusion (past year), etc.[73][74]. These factors help flag people in the window period of infection who might test negative but still harbor a virus.
- Men Who Have Sex with Men (MSM): This has been a particularly scrutinized criterion. FDA regulations once deferred any MSM activity within 5 years for tissue donors[70], due to higher statistical risk of HIV. In recent years, there has been movement toward individual risk assessment rather than blanket time-based deferrals. (For example, in April 2023 the FDA updated blood donor guidelines to remove categorical MSM deferrals in favor of assessing recent sexual history for all.) However, as of now, the tissue donor regulations have not officially been updated to that new model. So sperm banks often still exclude men who have had sex with men in the past 3-5 years for anonymous donation – unless perhaps they are in a monogamous low-risk relationship and meet new criteria (policies vary by bank). NYS regulation flatly states that persons with HIV high-risk behaviors per USPHS “shall not be accepted” as anonymous donors[75][72]. So an openly gay man, for instance, would typically only be able to donate to a partner or directed recipient with explicit consent. We anticipate this area will continue to evolve with societal and scientific changes (e.g. PrEP medication reducing HIV risk, etc.), but currently it remains a significant factor in donor eligibility.
- Recent Travel or Epidemic Exposures: Donors are screened for travel to regions with diseases like Zika virus, Ebola, or vCJD (variant Creutzfeldt-Jakob disease). For example, during the Zika outbreak in 2016, the FDA added donor screening questions about travel to areas with active Zika transmission. It recommended that donors be considered ineligible if they had traveled to a Zika-active area in the past 6 months, or had a diagnosis of Zika, or had sexual contact with someone who did[76]. A 6-month deferral was implemented for Zika risk because of uncertainty about how long the virus might persist in semen[77]. Similarly, donors who have been to places with high risk of malaria might be deferred from blood donation but for tissue donors the main concern is more for infectious diseases like HIV, HTLV, West Nile virus, etc. If a donor had a febrile illness in summer (possible West Nile Virus infection), they would likely be deferred for a certain period (the FDA has recommended 120 days deferral after a WNV infection for blood donors). There are also questions to exclude donors who in the past might have been exposed to prion disease – e.g. if someone lived in the U.K. during the peak “mad cow disease” years for a cumulative certain time, they might be deferred (this is a permanent deferral for blood; for sperm donation, many banks have historically applied similar caution to avoid any theoretical prion risk). All these are part of the screening interview.
- Medical History and Examination: The screening covers more than just infectious disease. Donors give a comprehensive personal and family medical history. NYS requires asking about “major genetic disorders” in the family, serious inherited diseases, etc., to assess risk to offspring[78][79]. They also ask about things like a history of cancer, chronic illnesses, etc., which might not exclude donation but are recorded for recipient information. On the infectious front, the physical exam looks for signs of sexually transmitted infections or other red flags: for example, genital lesions (which might indicate herpes or HPV), injection tracks on arms (which could imply IV drug use), jaundice (could mean hepatitis), swollen lymph nodes, or any acute illness signs. If a man shows up with a flu-like illness, fever, rash, etc., he would be deferred until fully evaluated. Some specific items from NYS regs: a semen donor’s exam should note any infectious skin disease that might risk contaminating the semen sample[80] (e.g. active genital psoriasis or severe skin infection might pose a contamination risk during collection). They even mention that if a semen donor reports a partner with trichomoniasis, that’s a factor to consider[81].
- Other Behavioral Exclusions: Donors are also screened for alcohol and drug abuse history[74], which could affect sperm quality and offspring health. And if a potential donor has a history of incarceration (since imprisonment is associated with higher risk of certain infections like TB, hepatitis B/C, etc.), that might be a deferral criterion (federal guidelines consider lockup >72 hours in past year a risk for TB and certain diseases). Additionally, having a recent tattoo or piercing (within 12 months) is typically a deferral for blood donors due to hepatitis risk; tissue donor screening likewise flags that (NYS included “history of…factors which place the donor at increased risk for HBV, HCV as determined by USPHS” which would include tattoos/piercings if not done in a regulated setting)[82].
The outcome of all this screening and testing is a Donor Eligibility Determination made by a qualified physician or donor program medical director. A donor is classified as “eligible” if:
- All required infectious disease tests are negative (or non-reactive), except CMV which can be positive and still eligible[61].
- The donor has no disqualifying risk factors or clinical evidence in the screening. This means the medical/social history did not reveal any barred behaviors or diagnoses, and the physical exam found no signs of infection or other concerning findings[83][84].
If either of those is not met, the donor is “ineligible.” The FDA requires that documentation be made of the reasons a donor was determined ineligible (e.g. “Donor is ineligible due to risk factor X” or “due to reactive test for hepatitis B core antibody”)[85]. Tissue banks must also keep a summary of records that travel with the specimen indicating the donor’s eligibility status[86].
What if a Donor Is “Ineligible”? – FDA “Exceptions” and Labeling
In general, if a donor is ineligible, their HCT/P (cells or tissue) cannot be used for transfer into another person. FDA regulations state that “an HCT/P must not be implanted, transplanted, infused, or transferred until the donor has been determined to be eligible”[87]. However, there are important exceptions written into the rules (21 CFR §1271.65(b)). The FDA allows use of cells from an ineligible donor in only a few special situations:
- Allogeneic use in a first-degree or second-degree blood relative of the donor. For example, if a man wanted to donate sperm to his brother or cousin, and he was found to have a disqualifying factor, this rule allows that related recipient to still use it[88][89]. (This might occur if, say, a brother is the only available match for sperm donation but is a carrier of hepatitis B – the family could decide to proceed under physician guidance, since they’re relatives.)
- Reproductive cells or tissue from a directed reproductive donor (who is not a sexually intimate partner)[90]. This is the case we’ve discussed: a directed sperm/egg donor who fails eligibility can still be used for the intended recipient if proper precautions are taken. The FDA defines a “directed reproductive donor” in this context and explicitly excludes intimate partners from that term (because intimate partners were never required to be eligible to begin with)[90]. So this exception is tailored to situations like known donor arrangements and surrogacy scenarios. In fact, the FDA guidance gives an example: in a gestational surrogacy, the couple (intended parents) are directed donors to the surrogate and must be screened/tested, but “the use of reproductive cells or tissue from an ineligible directed donor is not prohibited (with proper labeling)”[91]. It also notes that neither quarantine nor retesting is required for directed donor semen in such cases[34].
- Urgent Medical Need. If there is a documented urgent need (no comparable HCT/P is available and the recipient would likely die or suffer serious morbidity without it), an ineligible donor’s HCT/P can be used[92]. This is more applicable to situations like organ or bone marrow transplants in dire emergencies, rather than elective reproductive use. It’s hard to imagine a scenario where “urgent medical need” would apply to donor sperm or eggs – fertility is not an emergency. This provision is mainly for life-saving tissues (e.g., a last-minute need for a heart valve or bone graft when no eligible donor is available). It’s unlikely to be invoked in reproductive tissue banking.
If an HCT/P is used from an ineligible donor under these exceptions, stringent labeling and documentation are required. The container must be prominently labeled with the biohazard symbol (if any test is positive or risk identified) and a warning statement. Specifically, the FDA says to include: “WARNING: Advise patient of communicable disease risk,” and if a test was positive, “WARNING: Reactive test results for [name of disease]”[36]. So, for instance, a directed donor semen sample from an HIV-positive man would have a biohazard tag and a label stating “WARNING: Reactive test results for HIV-1” plus the general statement about communicable disease risk. Additionally, the recipient’s physician must be notified of the screening/testing results and the fact the donor was ineligible, and this notification must be documented[93]. Essentially, the use of an ineligible directed donation becomes a knowingly undertaken risk by the informed physician and recipient.This becomes even more challenging with New York State law mandating that any semen from a donor who tests repeatedly reactive for HIV-1 or HIV-2 antibodies must be destroyed (unless used in approved research)[42].
New York State mirrors this approach: It requires that if any directed donation with a high-risk factor is used, the recipient must give informed consent acknowledging the risks[35]. NYS also stipulates that tissues from a client-depositor who wasn’t originally tested (autologous) must be fully tested and stored 6 monthsbefore directed use[94] – effectively enforcing a retrospective quarantine to ensure safety.
It is important to stress that while these exceptions exist, they are not routine. Sperm banks and clinics will generally strongly advise against using an ineligible donor unless there is a compelling reason and no alternatives. For example, if a woman’s chosen directed sperm donor is found to have Hepatitis C, a clinic might refuse to assist unless there’s a clear understanding of risk and perhaps after the donor undergoes treatment (if possible) to clear the infection. In practice, the ineligible directed donor exception is most often used for situations like positive infectious disease screening tests that might be false or of unclear significance, or when the recipient insists on proceeding with a related donor despite something like a past infection. A common scenario is a CMV-positive donor being used for a CMV-negative recipient – since CMV positivity doesn’t make the donor ineligible per FDA, this doesn’t even need the exception; but it requires counseling that the baby could be exposed to CMV. Another scenario: a man with a treatable STD(say he tests positive for chlamydia) might donate to his wife (intimate partner, which is exempt anyway) after treatment, or a directed donor after treatment with a waiver of the waiting period – this would be handled case-by-case.
If a donor is ineligible and not covered by an exception, their stored samples must be segregated. FDA requires that HCT/Ps from ineligible donors be stored in a physically separate area or clearly identified to prevent accidental release[95]. Many sperm banks have separate cryotanks or separate labeled canisters for any units that are not to be used for general distribution (e.g. autologous HIV-positive samples). New York’s rules similarly require that semen from a donor who tests positive for HIV, HCV, HBV, etc., be immediately sequestered from other samples and labeled “For research use only” if it’s to be kept at all[39]. Cross-contamination in liquid nitrogen storage is extremely unlikely (especially with sealed vials), but as a precaution, vials from infectious positive donors are often stored in dedicated tanks or with double-containment.
To summarize this critical point: “Eligible” vs. “Ineligible” in FDA terms is essentially a pass/fail on the donor’s screening and testing. Eligible means the donor had no disqualifying risks and all tests are negative; their specimen can be used for any recipient without special waivers. Ineligible means something came up – using their specimen in someone else would violate regulations unless one of the explicit exceptions applies (directed donation, familial donation, or urgent need). Even in those cases, the law “calls out” the specimen with heavy warnings. If the ineligible donation is used, it’s done with eyes open to the risk.
Most clinics will involve an ethics committee or special consent process if someone insists on using an ineligible directed donor (e.g., an HIV-discordant couple using sperm washing and IVF to have a baby – that’s an example where the man is technically an ineligible donor, but since he’s the intimate partner, it’s allowed under the intimate partner exemption, and sperm washing is done to mitigate risk). In that example, the sample is labeled and processed in a way to protect lab personnel (with biohazard precautions) and the patient is counseled extensively.
Emerging Infectious Disease Issues (COVID-19, Zika, etc.)
The landscape of infectious disease concerns is always evolving. Regulations have adapted over time to new threats that could affect reproductive tissue safety:
- COVID-19: The emergence of SARS-CoV-2 in 2020 raised questions about viral presence in reproductive fluids and the safety of using gametes from donors who recently had COVID or were unvaccinated. The FDA addressed this in guidance to tissue establishments: notably, COVID-19 infection or vaccination status was not made part of donor eligibility criteria. The FDA did notrequire testing sperm donors for COVID-19, nor did it allow sperm banks to exclude or label donors based on whether they’d had the COVID vaccine[96][97]. This means sperm banks cannot, for example, advertise a donor as “vaccinated for COVID” or “unvaccinated” – and they do not collect that information as part of the official donor record[98][97]. The rationale: SARS-CoV-2 primarily spreads via respiratory droplets, and to date there have been no reported cases of COVID-19 transmission through donor sperm[99][100]. Early studies found little evidence of the virus in semen, especially once the acute phase had passed[101]. Thus, the FDA’s approach was to have tissue banks screen donors for any active infection (fever, symptoms) – a donor with symptomatic COVID-19 should obviously defer donation until recovered – but not to treat COVID exposure as a long-term deferral like Zika. For safety, many programs implemented a short deferral period (e.g. 28 days) after a COVID infection or close contact, out of caution, even if not required. But unlike Zika, the FDA never mandated a blanket 6-month deferral for COVID. By late 2021, with vaccines available, research showed COVID-19 vaccination does not impair sperm parameters or male fertility[102][103], easing concerns among patients considering donor sperm from vaccinated vs. unvaccinated individuals. In fact, studies indicated that a COVID infection itself could cause a transient drop in sperm quality, whereas the vaccine did not[104][105]. Professional societies (ASRM, ACOG) actively encourage vaccination for those trying to conceive, as COVID in pregnancy can pose risks[106]. For donor banks, the bottom line is: donors are screened for symptoms (and asked to refrain from donating while sick), but are not excluded for having had COVID nor required to be vaccinated. If a recipient is specifically concerned, they should discuss with their doctor – but they won’t find an official designation of donors by COVID status due to FDA rules[107]. This is a good example of regulators balancing a new risk – once data suggested minimal transmission risk via gametes, heavy restrictions were not imposed.
- Zika Virus: In 2016, Zika – which can be sexually transmitted and is known to persist in semen for extended periods – prompted quick action. The FDA issued guidance considering Zika a relevant communicable disease for HCT/P donors. They recommended deferring potential donors for 6 monthsafter any diagnosis of Zika, travel to areas with active Zika transmission, or sexual contact with a person at risk of Zika[76][77]. This effectively meant no donor who had recently been in parts of Latin America or Florida with Zika outbreaks could donate for half a year. Many sperm banks temporarily halted accepting donors from Florida or required self-quarantines during the height of Zika spread. The 6-month period was chosen out of caution due to limited data on viral persistence[108]. By 2018-2019, as Zika cases waned, these strict measures were eased. In May 2024, the FDA formally withdrew the Zika guidance, declaring Zika no longer a significant transfusion/transplant risk in the U.S.[109][110]. But the episode demonstrated how an emerging pathogen can swiftly become a required part of donor screening. Tissue banks keep an eye on CDC travel advisories and will adjust screening questionnaires in response to such threats. If Zika (or a similar virus) re-emerges, we could see deferrals reinstated. For now, Zika is a reminder in the history books of why sperm donation shifted to 100% frozen/quarantined (if it hadn’t already) and how sexual transmission concerns are addressed.
- West Nile Virus (WNV): West Nile, spread by mosquitoes, can be transmitted via blood transfusion or organ transplant. There is no required lab test for WNV in tissue donors, but donors are screened for symptoms of WNV infection (fever, headache in summer months) or a history of diagnosis. Blood donors are routinely NAT-tested for WNV during mosquito season; tissue donors could be tested if indicated, but more often a recent WNV infection would just lead to a temporary deferral. The FDA has advised that if a living donor had a confirmed WNV infection, they be deferred at least 120 days[111]. For sperm donors, many banks simply wouldn’t allow donation until well after recovery anyway. Luckily, WNV is usually a short-term illness, and the probability of getting it from a cryopreserved sperm sample is extremely low (there has been no documented case to our knowledge).
- Hepatitis A: Hepatitis A is not transmitted via semen or sexual fluids in the same way (it’s primarily fecal-oral), and it does not cause chronic infection. Thus, Hep A testing is not required for donors. However, if a donor were acutely ill with Hepatitis A (jaundice, etc.), they would obviously be deferred until completely recovered – as with any acute infection. In the early 2000s, some cases of assisted reproduction raised questions about Hepatitis B and A cross-contamination in IVF labs (since Hep A can be present in blood during acute phase). As a result, some clinics took measures to separate culture incubators for Hepatitis-positive patients. But as far as regulations, Hepatitis A is not on the required donor test list. The main hepatitis focus remains B and C because of their chronic carrier states.
- Emerging pathogens (Ebola, Mpox, etc.): From time to time new diseases prompt advisories. During the 2014 Ebola outbreak, for instance, the FDA recommended deferring donors who had traveled to Ebola outbreak regions or had exposure. Ebola RNA was found in semen of survivors for months, so theoretically that’s a risk (though these individuals were usually very ill and not donating). In 2022, the mpox (formerly called monkeypox) outbreak led some blood banks to screen donors for rash or diagnosis of mpox. A sperm donor with an active mpox infection would certainly be deferred (in fact, the lesions and symptoms would be obvious reasons to defer). These things haven’t made it into codified regulations but are handled via guidelines and the screening process (“Have you had any unexplained rash or been diagnosed with ____?” etc.). The regulatory framework is flexible enough to incorporate new questions quickly, even if the CFR text doesn’t list the disease by name. Tissue banks also rely on guidance documents from FDA and CDC alerts to update their screening SOPs.
One more topic worth noting in infectious risk management: sperm washing for HIV-discordant couples. In the case of a male partner with HIV wishing to conceive with an uninfected female partner, specialized clinics can process (wash) the sperm to minimize HIV transmission risk and then use it for IVF or intrauterine insemination. This practice is legal and has been successful in producing healthy babies without transmitting HIV to the mother or child. Under FDA rules, the man is technically an ineligible directed donor (since he’s donating sperm to his intimate partner, but actually intimate partners are exempt altogether from the rules[112]). Many clinics still follow an IRB-approved research protocol for sperm washing or require an informed consent similar to directed donation cases. The sperm sample in that scenario would be labeled with biohazard, etc., and lab staff use extra precautions. New York State law historically was very strict about HIV and reproductive tissue – at one point, NYS banned use of HIV-positive men’s sperm in assisted reproduction except under approved research protocols. But as of today, with modern techniques and antiretroviral therapy, there are established, safe methods for these couples. This is a tangential scenario that not many general readers will encounter, but it underscores how regulations aim to provide paths for even challenging cases (with appropriate safeguards).
FDA vs. New York State vs. International: A Quick Recap
By now, it’s clear that FDA and NYS regulations largely align on infectious disease safeguards. In fact, NYS often explicitly references the federal standards and then adds detail or additional requirements. For example, NYS requires genetic disease carrier screening for donors based on ethnicity (for Tay-Sachs, cystic fibrosis, etc.) – which is beyond the FDA’s infectious disease scope[6][113]. NYS also imposes an age limit notification (if a sperm donor is over 44 or egg donor over 34, the recipient’s physician must be notified due to potential risks of advanced paternal/maternal age)[114]. These are not infectious issues but show NYS’s comprehensive approach to donor quality. On the infectious side, differences are minor: NYS explicitly allows a quarantine waiver for directed semen with frequent interim testing[25], whereas FDA simply says quarantine is not required for directed donors[34]. NYS required HTLV-I testing; FDA requires HTLV I/II. NYS list included HIV-2 and HTLV-I at a time when FDA regs (in early 2000s) didn’t yet specifically mention them – so NY was slightly ahead in covering those. Both require syphilis, gonorrhea, chlamydia testing, etc.
Internationally, the UK’s HFEA and EU directives enforce similar infectious disease testing: HIV, Hep B, Hep C, syphilis for all donors, HTLV in those at risk, CMV in some cases, and so on[115][116]. The EUspecifically mandates a 180-day quarantine for sperm donations “other than by partners,” with repeat testing after, unless validated techniques like NAT are used to shorten the window[12]. Many European sperm banks take advantage of NAT (testing donor blood by PCR for viruses) to release sperm earlier than 6 months. For instance, a donor’s sample might be cleared after a much shorter quarantine if high-sensitivity NAT for HIV/HBV/HCV is negative at donation and again a month later. The U.S. FDA, conversely, has not adopted NAT in lieu of quarantine in its regulations – so even if a U.S. sperm bank runs NAT (some do to be extra sure), they are still bound to the 6-month retest rule for anonymous donors[29]. Canada’s recent regulations (implemented in 2020) also require a quarantine and retest at 6 months for sperm donors, similar to FDA, unless the donation is directed or for intimate partners[117].
In summary, whether you’re in New York, California, or abroad, if you engage with a licensed clinic for donor sperm or eggs, there is a robust system in place to minimize infectious disease risks. The specific pathogens tested are almost universally: HIV, Hepatitis B, Hepatitis C, Syphilis, Gonorrhea, Chlamydia, plus HTLV and CMV for sperm donors. Donors are thoroughly screened for risky behaviors or exposures. In the U.S., the term “Eligible Donor” means someone who passed all these hurdles; “Ineligible” means something was amiss – and those units will either be discarded or, in special cases, used with heavy precautions.
For patients and providers, it’s reassuring to know that these precautions have been extremely effective. Since mandatory testing and quarantining were instituted (initially by state programs like NY in the early 1990s in response to HIV, and nationally by FDA by 2005), there have been no known cases of HIV transmission via screened donor sperm, and similarly low to negligible instances of hepatitis or other infections from donor gametes. The system isn’t 100% foolproof (no biological system is), but it is highly protective.
Conclusion
Cryopreserving reproductive samples – whether for your own future use or for donating to help others – comes with a complex web of regulations designed for safety. Navigating these rules can be challenging, but it ultimately ensures that the joy of creating a family isn’t marred by an avoidable infection. In New York State, additional regulations complement the FDA’s, making the screening and testing process among the most rigorous in the world. We have discussed how HIV shaped much of the policy (e.g. the institution of quarantine and partner donation exceptions), how hepatitis B and C, syphilis, HTLV, CMV, and even novel viruses like Zika or SARS-CoV-2 are handled. We’ve differentiated anonymous vs. directed donors – illustrating why an anonymous donor’s sperm is frozen for 6 months and retested, whereas a directed donor’s might be used sooner with informed consent. We’ve clarified what happens when a donor is deemed “ineligible”, and that such specimens can only be used in limited circumstances with explicit warnings[36][22].
Our tone throughout has been factual yet compassionate, because we recognize that behind every donor or recipient is a human story. A man freezing sperm before chemotherapy might be anxious about infectious disease tests delaying his treatment – but knowing he’s a client-depositor and not subject to donor deferrals can be a relief. A couple seeking donor sperm might feel overwhelmed by the criteria – but can take comfort that any sperm sample they receive from a reputable bank has been through layers of safeguards. And healthcare providers referring patients to fertility preservation or third-party donation can use this information to counsel patients on what to expect: blood draws, questionnaires, possible deferrals for certain travel or tattoos, etc., all in the service of a healthy outcome.
As science advances, we may see further refinement of these rules – for instance, perhaps shorter quarantine periods if molecular testing is ultra-sensitive, or changes in deferral criteria to be more inclusive without sacrificing safety. But the core principles will remain: preventing communicable disease transmission in reproductive medicine, and transparently informing and protecting patients. Fertility clinics and tissue banks strive to maintain a warm, supportive environment while also being extremely diligent about these protocols. It’s a balancing act of compassion and caution – much like the tone of this article – and one that ultimately allows the miracles of assisted reproduction to happen safely.
References:
- FDA – “What You Should Know: Reproductive Tissue Donation.” U.S. Food & Drug Administration, content current as of April 25, 2019. Describes FDA oversight of sperm/egg donors, required infectious disease tests (HIV-1/2, HBV, HCV, syphilis, chlamydia, gonorrhea, plus HTLV and CMV for sperm), and screening procedures[3][57].
- 21 CFR Part 1271 – Donor Eligibility Rules (FDA). U.S. Code of Federal Regulations Title 21, Part 1271. Specifically: 21 CFR 1271.75 (donor screening), 1271.80-.85 (testing requirements), 1271.90 (exceptions). The FDA’s Guidance for Industry: Eligibility Determination for Donors of HCT/Ps (Feb 2007) further explains these rules[118][36]. Key points: sexually intimate partner donations are exempt[112]; directed donors must be screened/tested but ineligible directed donations can be used with labeling[22]; anonymous donors require quarantine and retest[29].
- New York Codes, Rules and Regulations – 10 NYCRR Part 52, Subpart 52-8 (Reproductive Tissue Banks). NYS Department of Health. Section 52-8.1 defines anonymous donor, directed donor, client-depositor[16]. Section 52-8.5 covers donor qualification criteria (medical/social history exclusions like HIV risk behaviors, STDs, etc.)[82][75]. Section 52-8.6 lists required lab tests: ABO/Rh, HIV-1/2, HTLV, HBV (HBsAg, anti-HBc), HCV, syphilis, gonorrhea, chlamydia, semen analysis; requires 6-month quarantine for semen with retest, with waiver allowed for directed donations with frequent interim testing[24][25]. Also mandates destruction of any donor semen reactive for HIV, HCV, HBV, etc., unless for approved research[39].
- NY State Department of Health – Tissue Bank Regulations (March 20, 2024 Update). The latest NYS Register update (Volume XLVI, Issue 12) affirms the above requirements and adds genetic carrier screening rules (10 NYCRR 52-8.6(h)): donors at risk for Tay-Sachs, cystic fibrosis, etc., must be tested[119][120]. Emphasizes that any reproductive tissue used in someone other than the source or their intimate partner triggers full donor qualification standards[9][10].
- FDA Guidance – “Use of Donor Specimens that Test Ineligible.” From FDA HCT/P Guidance and 21 CFR 1271.65. It states that reproductive cells from an ineligible directed donor may be used with proper labeling, and that such HCT/Ps must be marked with a Biohazard legend and warnings of communicable disease risk[36]. Also notes that quarantine and retesting are not required for directed donations (no 6-month hold)[34], whereas for anonymous donors, quarantine + 6-month retest is required and if the donor is ineligible the specimen may not be used[28].
- Seattle Sperm Bank – “COVID-19, Vaccines, and Donor Sperm” (2021–2022)[96][97]. Summarizes FDA’s COVID guidance: no requirement to test asymptomatic donors for SARS-CoV-2; no labeling of donor sperm by COVID vaccination status allowed. Indicates that sperm banks follow FDA standards which did not add COVID as a donor eligibility factor. This source also references studies showing COVID vaccination does not harm sperm quality[102].
- AHA News – FDA Zika Screening Recommendations (Mar 2016). American Hospital Association summary of FDA guidance[76][77]. Notes FDA’s 6-month deferral for donors with Zika risk (diagnosis, travel to active transmission area, or sexual contact with someone at risk). This was an example of an urgent response to an emerging pathogen, later relaxed as Zika waned.
- HFEA (UK) – “Home insemination with donor sperm” (2020). Explains UK clinic practices: all donor sperm is usually frozen and quarantined 180 days with donor retested before use[12], due to window periods for infections. If using fresh sperm (not quarantined), they suggest employing NAT testing to reduce risk[121]. This reflects international alignment on the 6-month quarantine rule and the option of advanced testing to mitigate it.
- ECDC Technical Report – “Laboratory testing of non-partner sperm donors” (2016). European Centre for Disease Prevention and Control report[122][13]. States that when NAT (PCR) testing for HIV, HBV, HCV is applied, the 180-day quarantine and repeat blood testing “is not recommended” (because NAT shortens the window period so much). Provides a scientific rationale used in EU to allow release of donations without 6-month wait if NAT is negative, given low residual risk.
- FDA Guidance – Donor Re-screening and Autologous Use Labeling. From 21 CFR 1271.90 and guidance[18][123]. Clarifies that for autologous donors (client-depositors), the package must be labeled “FOR AUTOLOGOUS USE ONLY” and “NOT EVALUATED FOR INFECTIOUS SUBSTANCES” if no testing was done. If such stored autologous cells are later intended for directed donation, then an eligibility determination and appropriate labeling (“Advise recipient of communicable disease risks”) must occur[124][125]. This reference emphasizes how autologous exceptions work and the labeling required when rules are waived.
Subscribe to our weekly blog here:
[1] [2] [3] [4] [5] [41] [48] [52] [57] What You Should Know – Reproductive Tissue Donation | FDA
[6] [7] [8] [9] [10] [15] [21] [35] [113] [119] [120] Genetic Carrier Screening & Donor Eligibility in NY
[11] NEW YORK STATE DEPARTMENT OF HEALTH
https://www.wadsworth.org/sites/default/files/WebDoc/DOH-2973%28d%29_0.pdf
[12] [121] Home insemination with donor sperm | HFEA
https://www.hfea.gov.uk/donation/donors/home-insemination-with-donor-sperm
https://www.ecdc.europa.eu/sites/default/files/documents/Testing-non-partner-sperm-donations.pdf
[14] [117] Guidance Document – Safety of Sperm and Ova Regulations
[16] [19] [20] [26] N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-8.1 – Definitions | State Regulations | US Law | LII / Legal Information Institute
https://www.law.cornell.edu/regulations/new-york/10-NYCRR-52-8.1
[17] [18] [22] [23] [28] [29] [30] [31] [33] [34] [36] [46] [47] [55] [56] [60] [61] [62] [66] [67] [68] [70] [83] [84][85] [86] [87] [88] [89] [90] [91] [92] [93] [95] [112] [118] [123] [124] [125] Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
[24] [25] [32] [37] [38] [39] [40] [42] [43] [44] [45] [49] [50] [53] [54] [58] [63] [64] [65] [94] N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-8.6 – Required laboratory tests | State Regulations | US Law | LII / Legal Information Institute
https://www.law.cornell.edu/regulations/new-york/10-NYCRR-52-8.6
[27] [69] [71] [72] [73] [74] [75] [78] [79] [80] [81] [82] [114] N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-8.5 – Donor qualifications | State Regulations | US Law | LII / Legal Information Institute
https://www.law.cornell.edu/regulations/new-york/10-NYCRR-52-8.5
[51] [59] [115] [116] L_2006038EN.01004001.xml
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32006L0017
[76] [77] [108] FDA recommends cell/tissue donor screening to reduce Zika transmission risk | AHA News
[96] [97] [98] [100] [102] [103] [104] [105] [106] [107] COVID-19, Vaccines, and Donor Sperm – Seattle Sperm Bank
[99] COVID-19 FAQs – California Cryobank
https://www.cryobank.com/covid-19-faqs
[101] [PDF] COVID and Sperm Donors – Fairfax Cryobank
https://fairfaxcryobank.com/wp-content/uploads/Fairfax-Cryobank-COVID-and-Sperm-Donors_UK.pdf
[109] Zika No Longer RCDA – FDA
[110] Information for Human Cells, Tissues, or Cellular or Tissue … – CDC
https://www.cdc.gov/zika/php/hctp-donation-establishments/index.html
[111] FDA issues recommendations to reduce the risk of Zika virus …