An Oakland, Calif., woman and her long-term partner wanted to start a family.
She did not want to have heterosexual intercourse, nor did she want to use a medical intermediary -- like a sperm bank or doctor -- and pay a fee to get pregnant.
Instead, she wanted to use a free sperm sample from a man she had chosen, and inseminate herself.
However, FDA regulations state that "any establishment that performs one or more manufacturing steps" for donating sperm samples -- from producing a sample, having it analyzed, storing it, to providing it to a recipient -- must register with the agency and get tested for communicable diseases that may be transmitted through artificial insemination.
These regulations may also apply to uncompensated donors, like the one she and her partner sought out.
After the recent cease order issued by the FDA to Trent Arsenault, a free sperm donor from Acampo, Calif., ordering him to stop "manufacturing" and supplying couples with sperm who are seeking to get pregnant, the woman wanted to err on the side of caution.
As a result, she is suing, under the name Jane Doe, the commissioner of the U.S. Federal Drug Administration (FDA) and the secretary of the U.S. Department of Health and Human Services, claiming its regulations violate her rights to privacy for telling her how she should be allowed to conceive a child.
"This means the FDA can reach into your bedroom and tell you how to procreate," said her lawyer, Amber Abbasi, chief counsel for regulatory affairs at government accountability advocacy organization Cause of Action.
"The FDA taking the position that donors, even when there's no commercial element, are 'an establishment,' just like a sperm bank and have to register," said Abbasi, "this is a serious burden on the reproductive freedoms of both the recipient and the donor."
Abbasi said her client wanted to obtain fresh donor sperm from an individual she selected and implant it herself in a process known as intracervical artificial insemination -- injecting the semen into her cervix -- using a syringe, which does not require medical supervision.
According to the lawsuit, Doe felt it was important for the biological father to be present in her child's life, if he or she so desired. Doe did not want to visit a sperm bank for an anonymous sample, a process noted to be "costly and burdensome" for couples looking to get pregnant.
Doe had selected a donor and did a review on his personal and medical history before attempting to conceive through intracervical insemination, said the suit. She did get pregnant, but she miscarried.
Doe wants to try again, but is concerned that "her choices of conception partner and method of conception are directly barred by FDA regulations," and is worried she will be charged with a federal crime if she opts to get pregnant in the way that she wants to, according to the lawsuit.
"It is a real problem for [the FDA] to treat women like Ms. Doe, who has to become pregnant by artificial insemination because she's in a lesbian relationship," said Abbasi.
Abbasi said the difference between homosexual and heterosexual couples getting pregnant in the government's view is that there is a syringe involved.
Doe's suit was filed in U.S. District Court for the Northern District of California on July 2. Abbasi said the FDA has not responded, and no court date has been set yet.
"This is the first lawsuit of its kind," said Mary Beth Hutchins, communications director for Cause of Action.
FDA spokeswoman Rita Chappelle told ABC News she could not comment on pending litigation.
"Every day that the FDA is enforcing these regulations and prohibiting her from procreative conduct she's chosen for herself is a day that her biological clock is ticking away," Abbasi said.