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FDA Compliance at SRM

Seattle Reproductive Medicine prioritizes building trust with our patients, firmly adhering to the FDA’s rigorous guidelines. Our commitment is to offer the safest and most effective fertility solutions.

Donor Requirements as per FDA

FDA Requirements for Egg Donors

  • Health Examinations for Donors: Prospective donors at Seattle Reproductive Medicine undergo comprehensive physical assessments to ensure they are fit for egg donation.
  • In-Depth Donor Questionnaires: Participation requires donors to complete detailed questionnaires.
  • Stringent Infectious Disease Testing: We conduct thorough infectious disease screenings at FDA-approved labs, either 30 days before or within 7 days after egg retrieval.
  • Eligibility Standards for Anonymous Donors: Anonymous donors must strictly comply with FDA tissue eligibility standards.
  • Procedures for Directed Egg Donations: In cases of known donors, if the tissue doesn’t meet usual standards, it can be used with proper labeling and informed consent.

FDA Requirements for Donor Embryos

  • Disease Testing for Egg and Sperm: Seattle Reproductive Medicine endeavors to conduct infectious disease tests on egg and sperm donors, including CMV and HTLV types I and II tests.
  • Usage of Non-Eligible Embryos: Embryos not meeting eligibility criteria can be used, provided they are correctly labeled, and informed consent is obtained.

FDA Requirements for Anonymous Sperm Donors

  • Physical Health Screenings: Each donor undergoes an extensive physical examination.
  • Comprehensive Questionnaires: A detailed questionnaire about medical history is mandatory.
  • Medical History Assessments: We conduct a full review of each donor’s medical history.
  • Infectious Disease Tests: Testing at FDA-certified labs includes checks for CMV and HTLV types I and II, conducted around the time of sperm collection.
  • Six-Month Quarantine Period: Donated sperm is quarantined for six months, with a subsequent re-test for infectious diseases.
  • Tissue Use Standards: Donors must meet FDA criteria for tissue usage.

FDA Requirements for Known Sperm Donors

  • Health Checks: Directed donors receive the same thorough physical examinations as anonymous donors.
  • Detailed Questionnaires: These donors also fill out extensive questionnaires about their health and personal history.
  • FDA-Approved Disease Testing: Infectious disease screenings are performed as per FDA guidelines.

We strictly observe all FDA regulations, upholding top safety and compliance standards in our egg donation program. For more information, you can consult the FDA’s guidelines here.

Rigorous Donor Screening and Evaluation

Our donor screening process is exhaustive, aligning with all FDA regulations. We conduct detailed medical, genetic, and psychological assessments, along with infectious disease testing.

FDA Testing for Female Donors Includes:

  • Various specific tests for infectious diseases, including Chlamydia, Gonorrhea, Hepatitis B, Hepatitis C, HIV, Syphilis, and West Nile Virus.

FDA Testing for Male Donors Includes:

  • Comprehensive tests for diseases like CMV, Chlamydia, Gonorrhea, Hepatitis B, Hepatitis C, HIV, HTLV, Syphilis, and West Nile Virus.

Exceptional Record Management

Seattle Reproductive Medicine keeps meticulous records, ensuring compliance and transparency in line with FDA standards for added safety.

Advanced Tissue Handling and Preservation

We employ the latest technology for processing and storing reproductive tissues, adhering to FDA guidelines to guarantee quality and safety.

Quality Assurance and Control

Our facility boasts stringent quality control systems, including frequent audits and staff training, ensuring compliance with and exceeding FDA standards.

Adherence to FDA Labeling and Packaging Standards

Seattle Reproductive Medicine follows strict FDA guidelines for the labeling and packaging of reproductive tissues, reducing risks of misidentification.

Emphasis on Patient Safety

We are committed to reporting any adverse events promptly, as per FDA regulations, to maintain the highest safety standards.

Accreditation and Compliance

Seattle Reproductive Medicine is not only registered with the FDA but also upholds the standards set by professional fertility organizations, reflecting our dedication to exceptional fertility care.