FDA Compliance at ORM
Commitment to Excellence in Fertility Care
ORM Fertility places immense value on the trust we share with our patients, ensuring adherence to the FDA's strict regulations. We are dedicated to providing the safest and most effective fertility treatments.
FDA Requirements for Donors
Egg Donor Requirements
- Health Assessments for Donors: Each potential donor at ORM Fertility undergoes a comprehensive physical examination to ensure suitability for egg donation.
- In-depth Donor Questionnaire: Donors must complete a thorough questionnaire as part of the participation process.
- Rigorous 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 Criteria: Anonymous donors are required to meet FDA tissue eligibility standards.
- Directed Donation Guidelines: For known donors, even if the tissue doesn't meet standard eligibility, it can be used with proper labeling and informed consent.
Requirements for Donor Embryos
- Testing for Oocyte and Sperm Sources: ORM Fertility aims to perform infectious disease testing on both egg and sperm donors, including for CMV and HTLV types I and II.
- Utilization of Ineligible Embryos: Embryos failing to meet eligibility can still be used, with necessary labeling and informed consent.
Guidelines for Anonymous Sperm Donors
- Physical Examinations for Donors: Every donor undergoes a detailed health examination.
- Comprehensive Donor Questionnaire: A full questionnaire covering medical history is mandatory.
- Medical History Review: An extensive medical history check is performed to identify any health risks.
- FDA-Approved Infectious Disease Testing: We conduct tests for CMV, HTLV types I and II, and other diseases within a specific timeframe around sperm collection.
- Six-Month Quarantine and Repeat Testing: Donated sperm is quarantined for six months, followed by a second round of testing.
- Tissue Use Eligibility: Donors must satisfy FDA tissue use standards.
FDA Protocols for Known Sperm Donors
- Health Check for Donors: Directed donors undergo a physical examination similar to anonymous donors.
- Detailed Donor Questionnaire: Known donors are required to complete an extensive questionnaire.
- Infectious Disease Testing: Testing is performed as per FDA guidelines in an approved laboratory.
Our strict adherence to FDA regulations ensures the highest safety and compliance standards in egg donation. For more details, refer to the FDA's guidelines here.
Thorough Donor Screening and Testing
Our donor screening is comprehensive, meeting all FDA requirements. We conduct extensive evaluations, including medical, genetic, and psychological assessments, and test for infectious diseases.
FDA Testing for Female Donors Includes:
- Various tests for infectious diseases include Chlamydia, Gonorrhea, Hepatitis B and C, HIV, Syphilis, and West Nile Virus.
FDA Testing for Male Donors Includes:
- A range of tests covering infectious diseases such as CMV, Chlamydia, Gonorrhea, Hepatitis B and C, HIV, HTLV, Syphilis, and West Nile Virus.
Rigorous Record-Keeping
ORM Fertility maintains detailed records, ensuring transparency and compliance with FDA standards for extra safety and reassurance.
Advanced Tissue Handling and Storage
We utilize state-of-the-art technology for handling and storing reproductive tissues, strictly following FDA guidelines for quality and safety.
Quality Control and Assurance
Our facilities are equipped with robust quality control and assurance systems, including regular audits and staff training, to meet or exceed FDA standards.
Compliance with Labeling and Packaging Norms
ORM Fertility adheres to stringent FDA requirements for labeling and packaging reproductive tissues, ensuring accuracy and minimizing risks.
Focus on Patient Safety
We are committed to promptly reporting adverse events in line with FDA regulations and maintaining the highest standards of safety.
Certification
ORM Fertility is FDA-registered and complies with standards set by professional fertility organizations, underscoring our commitment to top-tier fertility care.