Our Commitment to FDA Compliance

FDA Compliance

Our Commitment to FDA Compliance at Dominion Fertility

Ensuring the Highest Level of Fertility Care

At Dominion Fertility, we recognize that building trust is fundamental in our patient relationships. We are committed to adhering to the rigorous standards set by the FDA, providing secure and effective fertility treatment options.

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FDA Compliance in Donor Procedures

FDA Requirements for Egg Donors:

  • Detailed Donor Evaluations: Each prospective donor at Dominion Fertility undergoes a comprehensive health examination to confirm their suitability for egg donation.
  • Extensive Donor Questionnaires: Potential donors complete detailed questionnaires that assess their eligibility.
  • Stringent Infectious Disease Testing: We adhere to strict protocols for infectious disease testing in an FDA-certified lab, either in the 30 days before or within 7 days after egg retrieval.
  • Anonymous Donor Eligibility Standards: Anonymous donors must comply with FDA guidelines for tissue donation.
  • Procedures for Known Donors: In cases of directed donations, even if the tissues do not meet standard criteria, they can still be used with proper labeling and informed consent.

FDA Requirements for Donor Embryos:

  • Comprehensive Testing: We strive to perform infectious disease testing on both the egg and sperm sources, including CMV and HTLV types I and II.
  • Management of Ineligible Embryos: Embryos failing to meet eligibility criteria can still be used with proper labeling and informed consent.

FDA Requirements for Non-Identified Sperm Donors:

  • Rigorous Physical Examination: All sperm donors are thoroughly examined for their suitability.
  • In-Depth Donor Questionnaires: Required detailed questionnaires cover various health aspects.
  • Complete Medical History Assessment: Each donor’s medical history is exhaustively reviewed.
  • Infectious Disease Laboratory Testing: Testing for diseases including CMV and HTLV types I and II is performed at an FDA-approved facility.
  • Six-Month Quarantine with Subsequent Testing: Donated sperm undergoes a six-month quarantine followed by repeated testing.
  • Tissue Use Eligibility: All donors must meet FDA standards for tissue donation.

FDA Requirements for Known Sperm Donors:

  • Comprehensive Health Assessments: Similar protocols as for anonymous donors are followed.
  • Extensive Personal and Health Questionnaires: Donors must fill detailed questionnaires.
  • Infectious Disease Checks: Testing is conducted in line with FDA guidelines.
  • Usage of Ineligible Tissue: With proper labeling and consent, even ineligible tissue can be utilized.

Dominion Fertility strictly follows FDA guidelines to ensure the utmost safety and compliance in our egg donation process. More information on our adherence to FDA regulations can be found here.

Rigorous Donor Screening and Testing

Our donor screening is thorough, in compliance with FDA standards, including comprehensive medical, genetic, and psychological assessments, and rigorous testing for infectious diseases.

FDA Testing Protocols for Female Donors Include:

  • Chlamydia/Gonorrhea Nucleic Acid Test
  • Total Hepatitis B Core Antibody Test
  • Hepatitis B Surface Antigen Test
  • Hepatitis C Antibody Test
  • HIV/Hepatitis C/Hepatitis B Nucleic Acid Test
  • HIV-1/2 Plus O Enzyme Immunoassay
  • Syphilis IgG Antibody Test
  • West Nile Virus RNA Test

FDA Testing Protocols for Male Donors Include:

  • Cytomegalovirus Total Antibodies with Reflex to IgM and IgG
  • Chlamydia/Gonorrhea Nucleic Acid Amplification Test
  • Hepatitis B Core Antibody Total with Reflex to IgM
  • Hepatitis B Surface Antigen with Reflex to Hepatitis B Virus DNA Quantification
  • Hepatitis C Antibody with Reflex to Hepatitis C Virus RNA Quantification
  • HIV-1/Hepatitis C/Hepatitis B Virus Ultrio Nucleic Acid Test
  • HIV-1/2 Plus O Enzyme Immunoassay with Reflex to HIV-1 Quantification
  • Human T-Lymphotropic Virus Types I/II Antibody
  • Treponema pallidum IgG (Syphilis Antibody)
  • West Nile Virus RNA Test

Impeccable Record-Keeping Standards

Dominion Fertility maintains transparent, comprehensive records in line with FDA regulations, adding an extra layer of safety and reassurance.

Adherence to Tissue Handling and Storage Protocols

Utilizing advanced technology for tissue handling and storage, Dominion Fertility strictly follows FDA guidelines to ensure the highest quality and safety.

Quality Control and Assurance

Our facilities maintain robust quality control and assurance systems, including regular audits, staff training, and adherence to FDA standards, ensuring top-tier care.

Conforming to Labeling and Packaging Guidelines

We comply with strict FDA requirements for labeling and packaging.

Certification and Compliance

Dominion Fertility meets FDA registration requirements, and also adheres to the high standards set by professional fertility organizations, such as American Society for Reproductive Medicine (ASRM), underscoring our dedication to superior quality in fertility care.