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FDA Compliance

FDA Compliance at RGI

Setting the Standard in Fertility Treatment Excellence

At Reproductive Gynecology & Infertility, we believe that building a foundation of trust with our patients is crucial. Complying with the 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 the 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: Should tissue from a directed donor 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 aim to conduct thorough infectious disease screenings on both egg and sperm donors, including specific tests for CMV and HTLV types I and II.
  • Management of Non-Eligible Embryos: Embryos failing to meet standard criteria can be used with appropriate labeling and recipient consent.

FDA Requirements for Anonymous Sperm Donors

  • Rigorous Donor Physical Exams: All sperm donors undergo detailed physical examinations.
  • Thorough Donor Questionnaires: Donors must complete comprehensive questionnaires covering various health aspects.
  • Complete Medical History Reviews: Each donor's medical history is carefully assessed.
  • FDA-Approved Infectious Disease Lab Tests: Conducted within specific timeframes around sperm donation, including for diseases like CMV and HTLV.
  • Six-Month Quarantine and Follow-Up Testing: Donated sperm is quarantined and undergoes repeated testing after six months.
  • Tissue Donation Eligibility: All donors are evaluated against FDA standards.

FDA Requirements for Known Sperm Donors

  • Physical Examination Protocols: Similar to anonymous donors, known donors are subject to thorough physical examinations.
  • In-Depth Health and Personal Questionnaires: Extensive questionnaires are a prerequisite.
  • Mandatory Infectious Disease Screening: Adhering to FDA guidelines, testing includes a range of specific disease screenings.
  • Utilization of Non-Standard Tissue: Tissue that doesn't meet the usual criteria may be used with correct labeling and informed recipient consent.

Reproductive Gynecology & Infertility strictly adheres to these FDA guidelines, ensuring safety and compliance in our egg donation process. For further information on our adherence to FDA regulations, you can click here

Rigorous Donor Screening and Testing

Our comprehensive donor screening process is fully aligned with FDA standards, encompassing extensive medical, genetic, and psychological assessments and thorough infectious disease testing for the protection of our patients.

FDA Testing Standards for Female Donors Include:

  • 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 w/ reflex to IgM/IgG
  • 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 and Transparency

At Reproductive Gynecology & Infertility, we maintain thorough and transparent records of all procedures, donor information, and patient interactions, ensuring compliance with FDA regulations for added safety and reassurance.

Adherence to Tissue Handling and Storage Standards

We utilize the latest in tissue handling, processing, and storage technology, abiding strictly by FDA guidelines to ensure the highest quality and safety of these materials.

Quality Control and Assurance Measures

Our facilities are equipped with robust quality control and assurance systems, with regular audits and staff training to meet and surpass FDA standards, ensuring premium care levels.

Commitment to Labeling and Packaging Accuracy

We adhere to rigorous FDA requirements for labeling and packaging reproductive tissues, aiming for precise identification and minimizing any risk of errors.

Focus on Patient Safety

Reproductive Gynecology & Infertility is devoted to promptly reporting any adverse events in accordance with FDA regulations, helping us maintain the highest standards of safety and contributing to national safety monitoring.

Certification and Compliance Assurance

Reproductive Gynecology & Infertility is registered with the FDA registration and also meets the criteria set by professional fertility organizations, including American Society for Reproductive Medicine (ASRM), reaffirming our commitment to delivering top-notch fertility care.