Pinnacle Fertility FDA Compliance

FDA Compliance

Our Commitment to FDA Compliance at Pinnacle Fertility

Upholding the Highest Standards in Fertility Care

At Pinnacle Fertility, we understand that trust is the foundation of our relationship with our patients. Adhering to the stringent regulations set by the FDA, we are dedicated to providing the safest and most effective fertility treatments.

FDA Requirements for Donors

FDA Requirements for Egg Donors

  • Physical Examination for Donors: All potential donors at our facility undergo a detailed physical examination. This thorough evaluation ensures they are fit and suitable for the egg donation process.
  • Comprehensive Donor Questionnaire: To participate, donors fill out a comprehensive questionnaire. 
  • Infectious Disease Testing Protocol: Our protocol involves conducting rigorous tests for infectious diseases at an FDA-approved laboratory. These crucial tests are administered in the 30 days prior to or within 7 days following the collection of eggs.
  • Criteria for Anonymous Donor Eligibility: For donors who choose to remain anonymous, adherence to FDA standards for tissue eligibility is a strict requirement.
  • Guidelines for Directed Donations: In situations involving directed (known) donors, there might be instances where the donated tissue does not meet standard eligibility criteria. In such cases, the tissue can still be utilized, provided it is appropriately labeled and consent is obtained in accordance with the required guidelines.

FDA Requirments for Donor Embryos

  • Infectious Disease Testing for Oocyte and Sperm Sources: When feasible, we attempt to conduct infectious disease testing on both the oocyte (egg) and sperm sources. This includes testing for CMV (Cytomegalovirus) and HTLV (Human T-Lymphotropic Virus) types I and II, with IgM and IgG testing on the sperm source.
  • Use of Ineligible Embryos: Embryos that are deemed ineligible can still be utilized. In such cases, the tissue must be appropriately labeled, and recipients must provide informed consent before use.

FDA Requirements for Non-Identified (Anonymous) Sperm Donors:

  • Donor Physical Examination: Each donor undergoes a thorough physical exam to ensure their suitability for sperm donation.
  • Donor Questionnaire: Donors are required to complete a detailed questionnaire covering various aspects, including medical history.
  • Medical History Review: A comprehensive review of the donor's medical history is conducted to assess any potential health risks.
  • Infectious Disease Laboratory Tests: We perform infectious disease testing at an FDA-approved laboratory, including tests for CMV and HTLV types I and II IgM and IgG, within 7 days before or after sperm acquisition.
  • Six-Month Quarantine with Repeat Testing: Donated sperm is quarantined for six months, followed by repeat infectious disease testing.
  • Eligibility for Tissue Use: Donors must meet the eligibility criteria to use tissue as per FDA standards.

FDA Requirements for Directed (Known) Sperm Donors:

  • Donor Physical Examination: Similar to anonymous donors, directed donors also undergo a comprehensive physical examination.
  • Donor Questionnaire: These donors are also required to fill out an extensive questionnaire regarding their medical and personal history.
  • Infectious Disease Laboratory Tests: Infectious disease testing, including CMV and HTLV types I and II IgM and IgG, is conducted within 7 days of sperm acquisition at an FDA-approved laboratory.
  • Use of Ineligible Tissue: In cases where the sperm tissue is ineligible, it can still be used, provided there is appropriate labeling and informed consent from the recipient.

We adhere to all FDA requirements as a part of our commitment to maintaining the highest standards of safety and compliance in our egg donation process. For further details on our adherence to FDA requirements, you can refer to the FDA's guidelines here.

Stringent Donor Screening and Testing

Our donor screening process is thorough and complies with all FDA requirements. We conduct extensive medical, genetic, and psychological evaluations and ensure all donors are tested for infectious diseases to protect the health and safety of our patients.

FDA Female Donor Testing Includes:

  1. CT/NG NAT - Chlamydia/Gonorrhea Nucleic Acid Test
  2. HBcAb, Total - Total Hepatitis B Core Antibody Test
  3. HBsAg - Hepatitis B Surface Antigen Test
  4. HCV Ab - Hepatitis C Antibody Test
  5. HIV-1/HCV/HBV Ultrio NAT - HIV/Hepatitis C/Hepatitis B Nucleic Acid Test
  6. HIV-1/2 Plus O EIA - HIV-1/2 Plus O Enzyme Immunoassay
  7. T. pallidum, IgG (Syphilis) - Syphilis IgG Antibody Test
  8. West Nile Virus, RNA - West Nile Virus RNA Test

FDA Male Donor Testing Includes:

  1. CMV, Total w/ reflex to IgM/IgG - Cytomegalovirus Total Antibodies with Reflex to IgM and IgG
  2. CT/NG NAT -  Chlamydia/Gonorrhea Nucleic Acid Amplification Test
  3. HBcAb, Total w/ reflex to IgM - Hepatitis B Core Antibody Total with Reflex to IgM
  4. HBsAg w/ reflex to HBV DNA Quant - Hepatitis B Surface Antigen with Reflex to Hepatitis B Virus DNA Quantification
  5. HCV Ab w/ rfx to HCV RNA Quant - Hepatitis C Antibody with Reflex to Hepatitis C Virus RNA Quantification
  6. HIV-1/HCV/HBV Ultrio NAT - HIV-1/Hepatitis C/Hepatitis B Virus Ultrio Nucleic Acid Test
  7. HIV-1/2 Plus O EIA w/reflex to HIV-1, Quant - HIV-1/2 Plus O Enzyme Immunoassay with Reflex to HIV-1 Quantification
  8. HTLV I/II Ab - Human T-Lymphotropic Virus Types I/II Antibody
  9. T. pallidum, IgG (Syphilis) - Treponema pallidum IgG (Syphilis Antibody)
  10. West Nile Virus, RNA - West Nile Virus RNA Test

Impeccable Record-Keeping Standards

We maintain comprehensive records of all procedures, donor information, and patient interactions. Our record-keeping practices are designed to be transparent and fully compliant with FDA standards, providing an extra layer of safety and reassurance.

Adherence to Tissue Handling and Storage Protocols

Pinnacle Fertility utilizes cutting-edge technology for the handling, processing, and storage of reproductive tissues. We strictly follow FDA guidelines to ensure the highest quality and safety of these materials.

Quality Control and Assurance

Our facilities have robust quality control and assurance systems. We conduct regular audits and staff training and ensure all equipment and procedures meet or exceed FDA standards, guaranteeing the highest level of care.

Conforming to Labeling and Packaging Guidelines

We adhere to strict FDA requirements for labeling and packaging of reproductive tissues, ensuring accurate identification and minimizing the risk of mix-ups.

Prioritizing Patient Safety

Pinnacle Fertility is committed to promptly reporting any adverse events in line with FDA regulations. This practice helps us maintain the highest safety standards and contribute to national safety monitoring.

Certification and Compliance

Pinnacle Fertility is not only FDA-registered but also complies with the standards of professional fertility organizations, reaffirming our commitment to excellence in fertility care.