Fertility / IVF Clinic Launch Roadmap
State-specific compliance overview for opening a facility in California.
Nurse Practitioner Practice Authority & Collaboration Agreement
NP practice authority varies by state: FULL (independent practice), REDUCED (collaborative agreement required), or RESTRICTED (physician supervision required). Whether an NP can own and run the clinic without a physician depends on this tier.
Confirm your state's NP practice tier, and where required, execute and file a written collaboration/supervision agreement with a physician before the NP evaluates patients or prescribes.
CLIA High-Complexity Certification — Embryology & Andrology Lab
IVF embryology and andrology laboratories perform high-complexity testing and must hold a CLIA Certificate of Compliance or Accreditation (not a simple waiver), with a qualified high-complexity lab director.
Apply for CLIA certification at the high-complexity level, appoint a qualified laboratory director (HCLD or equivalent), and pursue CAP/SART lab accreditation.
FDA Tissue Establishment Registration (21 CFR Part 1271)
Facilities that recover, process, store, or distribute reproductive tissue (oocytes, sperm, embryos) are HCT/P establishments and must register with the FDA, screen/test donors, and follow current good tissue practice (CGTP).
Register the facility with FDA as a tissue establishment, implement donor eligibility screening and testing SOPs, and maintain CGTP-compliant processing and storage records.
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