TRENTON, N.J. — New Jersey has adopted what state officials say are the nation’s first comprehensive regulations governing facilities that store and cryopreserve human eggs and embryos, establishing statewide licensing and safety standards for a rapidly growing area of reproductive medicine.
The New Jersey Department of Health announced the adoption of the rules, which create oversight requirements for embryo storage facilities involved in assisted reproductive technology, including in-vitro fertilization clinics, reproductive laboratories, hospitals and other medical practices that store human eggs or embryos.
Use of assisted reproductive technology has increased sharply in recent years. In 2022, fertility clinics in New Jersey performed nearly 13,000 assisted reproductive technology procedures, resulting in more than 5,500 live births, according to the Centers for Disease Control and Prevention. Until now, oversight of egg and embryo storage has largely relied on a combination of federal agencies and voluntary professional standards, without a dedicated state regulatory framework.
State officials said the new rules are intended to address that gap by setting standards for equipment safety, facility operations, emergency preparedness and recordkeeping.
“Today, we are setting a national standard for safe embryo storage. Undergoing fertility services can be an emotional and life-altering process for New Jerseyans trying to start a family. The last thing patients undergoing fertility services should have to worry about is whether their eggs and embryos are stored correctly,” Gov. Phil Murphy said. “By setting clear regulations, we are holding embryo storage facilities in New Jersey to a higher standard and ensuring patients focus on what matters most in their pursuit of parenthood.”
Acting Health Commissioner Jeff Brown said the regulations are designed to give patients greater confidence in the care and security of their reproductive tissue.
“The decision to pursue fertility treatment is deeply personal, and New Jerseyans deserve to know that the facilities storing their eggs and embryos meet rigorous standards,” Brown said. “With these rules, New Jersey is setting a national benchmark for protecting people hoping to start or grow their families as they navigate one of the most significant and complicated periods in their lives.”
Under the rules, facilities that store human eggs and embryos must apply for licensure with the Department of Health and comply with requirements covering equipment maintenance, emergency planning, quality management, reporting and recordkeeping. Facilities must also have safeguards such as backup power systems, oxygen sensors in rooms using liquid nitrogen, and remote alarm systems on cryogenic storage equipment.
Most facilities will be required to maintain accreditation through either the College of American Pathologists’ Reproductive Accreditation Program or the Joint Commission on Accreditation of Healthcare Organizations’ laboratory or office-based surgery programs. Facilities required to register with the U.S. Food and Drug Administration as Human Cell and Tissue establishments must demonstrate current registration.
Additional provisions require written policies addressing the disposition of reproductive tissue in cases such as facility closure, a client’s death or incapacity, or nonpayment of storage fees. Facilities must also report equipment failures or emergencies that could affect stored tissue and maintain certain records for at least 10 years after reproductive tissue is released for use.
The regulations were developed with input from an advisory panel that included experts in embryology, reproductive medicine, biobanking management, laboratory operations and reproductive rights.
State health officials said the rules are intended to reduce the risk of preventable equipment failures that have led to losses of stored reproductive tissue in other states.
The regulations took effect with publication of a Notice of Adoption in the Dec. 15, 2025, New Jersey Register. Facilities currently operating in New Jersey must notify the Department of Health by Jan. 15, 2026, of their intent to apply for licensure and submit full applications by Feb. 13, 2026. Facilities that are accredited and in good standing may continue operating under provisional licensure while their applications are reviewed.
The rules implement requirements established by legislation enacted in 2019 and amended in 2022.
