FDA Compliance

Our Commitment to FDA Compliance 

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Maintaining the Highest Levels of Fertility Care

At Advanced Fertility Care, we recognize that the cornerstone of our patient relationships is trust. We are steadfast in our adherence to the strict regulations of the FDA, ensuring the provision of the safest and most efficacious fertility treatments.

FDA Standards for Donor Processes

FDA Requirements for Egg Donors:

  • Thorough Donor Physical Examinations: We conduct exhaustive physical examinations of all potential donors, affirming their fitness and appropriateness for the egg donation process.
  • Detailed Donor Questionnaires: Our donors complete in-depth questionnaires which helps determine their donation eligibility.
  • Infectious Disease Testing Protocol: We follow a stringent protocol for infectious disease testing at an FDA-certified laboratory, which takes place in the 30 days before or within 7 days after egg retrieval.
  • Eligibility Requirements for Anonymous Donors: Anonymous donors must strictly adhere to FDA criteria for tissue donation eligibility.
  • Guidelines for Known Donor Donations: In cases of directed donations, even if the donated tissue does not meet all eligibility criteria, it can be used with proper labeling and informed consent.

FDA Requirements for Donor Embryos:

  • Testing for Oocyte and Sperm Sources: Where possible, we conduct tests for infectious diseases on both the egg and sperm donors, including CMV and HTLV types I and II, with specific antibody testing.
  • Usage of Ineligible Embryos: We may use embryos that do not meet eligibility standards, given that they are correctly labeled and recipients have given informed consent.

FDA Requirements for Anonymous Sperm Donors:

  • Comprehensive Donor Physical Exams: Each donor is rigorously examined to ensure their suitability for sperm donation.
  • Extensive Donor Questionnaires: Required in-depth questionnaires cover a range of health aspects.
  • Thorough Medical History Reviews: We evaluate each donor's medical history to identify potential health risks.
  • FDA-Approved Infectious Disease Testing: Includes testing for diseases such as CMV and HTLV types I and II within specific timeframes around sperm donation.
  • Six-Month Quarantine and Subsequent Testing: A six-month quarantine period for donated sperm is followed by repeated infectious disease testing.
  • Tissue Use Eligibility: All donors are evaluated to ensure they meet FDA tissue use standards.

FDA Requirements for Known Sperm Donors:

  • Physical Examinations: Known donors undergo similar physical examinations as anonymous donors.
  • Detailed Personal and Health Questionnaires: These donors complete comprehensive questionnaires.
  • Mandatory Infectious Disease Testing: Testing is performed in accordance with FDA guidelines.
  • Utilization of Ineligible Tissue: Even ineligible sperm tissue may be used with proper labeling and informed recipient consent.

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We strictly adhere to FDA guidelines, ensuring safety and compliance in our egg donation process. For additional information about our compliance with FDA regulations, please click here. 

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Thorough Donor Screening and Testing Process

Our screening process for donors is exhaustive and aligns with all FDA requirements. This includes detailed medical, genetic, and psychological evaluations, alongside thorough testing for infectious diseases to safeguard patient health.

FDA Testing for Female Donors Includes:

  • 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 for Male Donors Includes:

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

Impeccable Record-Keeping Standards

We maintain detailed records of all procedures, donor information, and patient interactions, ensuring transparency and full compliance with FDA standards.

Adherence to Tissue Handling and Storage Protocols

Advanced Fertility Care employs the latest technology in managing, processing, and storing reproductive tissues, strictly following FDA guidelines for quality and safety.

Quality Control and Assurance

Our facilities feature robust quality control and assurance systems, undergoing regular audits and staff training to ensure that all equipment and procedures not only meet but exceed FDA standards.

Conforming to Labeling and Packaging Guidelines

We strictly follow FDA regulations for labeling and packaging of reproductive tissues to ensure precise identification and minimize the risk of errors.

Prioritizing Patient Safety

Advanced Fertility Care is dedicated to promptly reporting any adverse events in accordance with FDA regulations, maintaining the highest standards of safety, and contributing to national safety monitoring.

Certification and Compliance

Advanced Fertility Care is FDA-registered and adheres to the standards set by professional fertility organizations, reinforcing our commitment to providing exceptional fertility care.