FDA Compliance

FDA Compliance at IVF-MI
Setting the Standard in Fertility Treatment Excellence

At IVF Michigan and Ohio, we believe that building a foundation of trust with our patients is crucial. Complying with stringent FDA guidelines, we are committed to delivering the most secure and effective fertility treatments available.

FDA Requirements for Donors

FDA Requirements for Egg Donors:

  • In-Depth Physical Assessments for Donors: Every potential donor undergoes a rigorous physical examination to ensure their readiness and suitability for the egg donation process.
  • Extensive Donor Questionnaire: Prospective donors are required to complete a detailed questionnaire.
  • Infectious Disease Testing Procedures: In line with FDA standards, we conduct comprehensive infectious disease testing at an approved laboratory, either within 30 days preceding or 7 days following egg retrieval.
  • Requirements for Anonymous Donor Eligibility: We ensure that anonymous donors strictly meet the FDA’s tissue donation standards.
  • Guidelines for Known Donor Donations: If tissue from a directed donor does not meet certain criteria, it can still be utilized, subject to proper labeling and the recipient’s informed consent.

FDA Requirements for Embryo Donors:

  • Testing for Oocyte and Sperm Sources: We conduct thorough infectious disease screenings on both egg and sperm donors, including tests for CMV and HTLV types I and II.
  • Management of Non-Eligible Embryos: Embryos that do not meet FDA criteria may still be used with appropriate labeling and recipient consent.

FDA Requirements for Anonymous Sperm Donors:

  • Rigorous Donor Physical Exams: All sperm donors undergo comprehensive physical examinations.
  • Thorough Donor Questionnaires: Donors must complete in-depth questionnaires addressing a wide range of health factors.
  • Complete Medical History Reviews: Each donor’s medical history is carefully reviewed.
  • FDA-Approved Infectious Disease Lab Tests: These tests are conducted within specific timeframes around sperm donation and include CMV, HTLV, and other critical screenings.
  • Six-Month Quarantine and Follow-Up Testing: Donated sperm is quarantined and re-tested after six months to confirm donor health.
  • Tissue Donation Eligibility: All donors are evaluated against FDA standards to confirm compliance.

FDA Requirements for Known Sperm Donors:

  • Physical Examination Protocols: Known donors undergo the same thorough examinations as anonymous donors.
  • In-Depth Health and Personal Questionnaires: Extensive questionnaires are required prior to donation.
  • Mandatory Infectious Disease Screening: Testing is conducted in strict accordance with FDA guidelines.
  • Utilization of Non-Standard Tissue: Tissues not meeting standard criteria may still be used if correctly labeled and accompanied by recipient consent.

IVF Michigan and Ohio strictly adheres to these FDA guidelines, ensuring safety and compliance in our egg and sperm donation programs. For further information on our adherence to FDA regulations, [click here].

Rigorous Donor Screening and Testing

Our comprehensive donor screening process is fully aligned with FDA standards, encompassing detailed medical, genetic, and psychological evaluations, along with thorough infectious disease testing to safeguard our patients.

FDA Testing Standards for Female Donors Include:

  • CT/NG NAT
  • HBcAb, Total
  • HBsAg
  • HCV Ab
  • HIV-1/HCV/HBV Ultrio NAT
  • HIV-1/2 Plus O EIA
  • T. pallidum, IgG (Syphilis)
  • West Nile Virus, RNA

FDA Testing Standards for Male Donors Include:

  • CMV, Total with reflex to IgM/IgG
  • CT/NG NAT
  • HBcAb, Total with reflex to IgM
  • HBsAg with reflex to HBV DNA Quant
  • HCV Ab with reflex to HCV RNA Quant
  • HIV-1/HCV/HBV Ultrio NAT
  • HIV-1/2 Plus O EIA with reflex to HIV-1 Quant
  • HTLV I/II Ab
  • T. pallidum, IgG (Syphilis)
  • West Nile Virus, RNA

Impeccable Record-Keeping and Transparency

At IVF Michigan and Ohio, we maintain comprehensive and transparent records of all procedures, donor data, and patient interactions. This ensures full compliance with FDA regulations and provides added confidence and peace of mind for our patients.

Adherence to Tissue Handling and Storage Standards

We utilize advanced technology for tissue handling, processing, and storage, complying fully with FDA protocols to ensure the safety and integrity of all reproductive materials.

Quality Control and Assurance Measures

Our clinics are equipped with rigorous quality control and assurance systems, including regular audits and ongoing staff training, to ensure we meet and exceed FDA requirements at every level.

Commitment to Labeling and Packaging Accuracy

We follow all FDA-mandated labeling and packaging standards for reproductive tissues, ensuring accuracy in identification and reducing any risk of procedural error.

Focus on Patient Safety

IVF Michigan and Ohio is committed to the timely reporting of any adverse events in full compliance with FDA standards, reinforcing our commitment to safety and continuous improvement.

Certification and Compliance Assurance

IVF Michigan and Ohio is fully registered with the FDA and meets all accreditation standards from professional bodies such as the American Society for Reproductive Medicine (ASRM), underscoring our dedication to excellence in fertility care.