FDA Clears First At-Home Kit for Artificial Insemination

— Intravaginal device was deemed "substantially equivalent" to clinically used intrauterine device

by Rachael Robertson, Enterprise & Investigative Writer, 番茄社区 December 7, 2023

A photo of the components of the Mosie Baby Kit

The FDA cleared the first , maker Mosie Baby announced on Wednesday.

Determined by the agency to be "substantially equivalent" to a device that's already used in clinics for intrauterine insemination, the Mosie Baby Kit is designed for use with fresh or cryogenically frozen sperm, . It is indicated for individuals who have been unable to, or choose not to, conceive through intercourse. Each kit comes with two syringes and two collection cups for holding sperm, all of which are single-use and non-sterile.

Similar at-home kits are already on the market, but in 2020, the FDA sent a to a company selling such kits with components intended for use in animals.

In its letter, the FDA said that catheters for assisted reproduction are considered class II devices, but as Tenderneeds Fertility did not pursue clearance via the agency's 510(k) or premarket approval (PMA) pathways, the kits could therefore not be legally marketed. Tenderneeds Fertility kits were and the company is no longer in business as of August 2021, .

Other at-home artificial insemination kits currently on the market include those made by and . PherDal states on its website that it is seeking "to develop the world's first FDA-cleared, at-home artificial insemination kit that's 100% sterile and affordable."

In addition to tests to demonstrate shelf life, bioburden, function, sperm survival, and biocompatibility, Mosie Baby conducted .

A self-selection study showed that potential users were able to accurately determine whether they should use the product, and how to use it, along with its contraindications. A human factors validation study showed potential users could successfully use it by reading only the label information.

The predicate device used for clearance of the Mosie Baby kit is the Shepard Intrauterine Insemination Set, which is used by clinicians.

In its , FDA noted that the at-home kit and the predicate device are different in several ways. For instance, Mosie Baby "is for delivery of semen/sperm to the vagina, while the predicate device is for delivery of washed spermatozoa to the uterine cavity."

The Mosie Baby kit retails for $129.99. Its syringe has a barrel-free tip and slit opening that "optimizes transfer while minimizing waste," the company stated. It noted that consumers should use the product twice per ovulation cycle for best results, which is why the kit comes with supplies for two attempts.

Rachael Robertson is a writer on the 番茄社区 enterprise and investigative team, also covering OB/GYN news. Her print, data, and audio stories have appeared in Everyday Health, Gizmodo, the Bronx Times, and multiple podcasts.