IHR Legal Document

FDA Compliance

Our Dedication to FDA Compliance at Institute for Human Reproduction

Ensuring Excellence in Fertility Care

At the Institute for Human Reproduction, we firmly believe that trust is essential in our patient relationships. Committed to adhering to the rigorous standards set by the FDA, our goal is to offer the safest and most effective fertility treatments available.

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FDA Compliance in Donor Protocols

FDA Requirements for Egg Donors

  • Exhaustive Physical Assessments for Donors: All potential donors at our institute undergo detailed physical evaluations, ensuring their fitness and appropriateness for egg donation.
  • In-Depth Donor Questionnaires: Donors complete a thorough questionnaire, covering medical, genetic, and psychological aspects to ascertain their suitability for donation.
  • Protocol for Infectious Disease Testing: We conduct strict infectious disease tests at an FDA-approved laboratory, either 30 days before or within 7 days after egg collection.
  • Anonymous Donor Eligibility Requirements: Anonymous donors are required to meet FDA criteria for tissue eligibility.
  • Directed Donation Guidelines: In cases of known donors, donated tissues that don't meet all eligibility criteria may still be used, subject to proper labeling and informed consent.

FDA Requirements for Donor Embryos:

  • Testing for Egg and Sperm Sources: We aim to perform infectious disease screenings for both egg and sperm donors, including tests for CMV and HTLV types I and II.
  • Use of Non-Eligible Embryos: Embryos failing to meet certain criteria may be used, provided they are appropriately labeled and consented for use.

FDA Requirements  for Anonymous Sperm Donors:

  • Thorough Donor Physical Examinations: Each sperm donor undergoes a comprehensive health exam.
  • Detailed Donor Questionnaires: Donors must complete extensive questionnaires, addressing various health aspects.
  • Comprehensive Medical History Reviews: We evaluate each donor's medical history thoroughly.
  • Infectious Disease Laboratory Testing: Tests including CMV and HTLV types I and II are performed around the time of sperm donation at an FDA-certified lab.
  • Six-Month Quarantine and Repeat Testing: Donated sperm undergo a six-month quarantine and subsequent infectious disease testing.
  • Criteria for Tissue Use Eligibility: Donors must comply with FDA standards for tissue donation.

FDA Requirements for Known Sperm Donors:

  • Physical Examination Protocols: Similar to anonymous donors, known donors are subjected to detailed physical exams.
  • Extensive Health and Personal History Questionnaires: These donors must complete thorough questionnaires.
  • Required Infectious Disease Testing: Conducted per FDA guidelines, including specific disease screenings.
  • Utilization of Non-Standard Tissue: Tissues not meeting usual criteria may be used, given proper labeling and informed recipient consent.

At the Institute for Human Reproduction, we adhere to all FDA regulations to ensure the highest levels of safety and compliance in our egg donation process. For more details on our compliance, please click here.

Rigorous Donor Screening and Testing

Our donor screening process is thorough, fully aligning with FDA requirements. It includes medical, genetic, and psychological evaluations, and comprehensive testing for infectious diseases to ensure patient safety.

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

Commitment to Detailed Record-Keeping

We maintain comprehensive and transparent records of all procedures, donor information, and patient interactions, ensuring adherence to FDA standards for added reassurance and safety.

Adherence to Tissue Handling and Storage Practices

Institute for Human Reproduction employs advanced technology for tissue handling, processing, and storage, strictly following FDA guidelines to ensure superior quality and safety.

Quality Control and Assurance

Our facilities are equipped with comprehensive quality control and assurance systems. We conduct regular audits, provide staff training, and ensure all equipment and procedures exceed FDA standards, guaranteeing the highest level of care.

Conformance to Labeling and Packaging Standards

We strictly adhere to FDA requirements for labeling and packaging of reproductive tissues, ensuring accurate identification and reducing the risk of errors.

Prioritizing Patient Safety

Institute for Human Reproduction is committed to promptly reporting any adverse events in compliance with FDA regulations, helping us uphold the highest safety standards, and contribute to national safety monitoring.

Certification and Regulatory Compliance

Institute for Human Reproduction is not only registered with the FDA but also complies with the standards of professional fertility organizations, reinforcing our dedication to exceptional fertility care.