This Test Represented a Turning Point in IVF History

The recent hubbub over Democratic Vice Presidential Candidate Tim Walz's representation of his and his wife's fertility journey has brought in vitro fertilization (IVF) into the spotlight. Walz faced backlash last week for implying that he and his wife, Gwen, used IVF. In truth, the couple used intrauterine insemination (also known as artificial insemination) for reproductive assistance.

So, it seemed an appropriate time to look back at a major turning point in IVF history.

FDA originally assigned Auxogyn's Eeva System into Class III on August 3, 2012. Later that month, Auxogyn requested classification as a Class II device, a necessary step under the de novo classification process. FDA reviewed the request and decided Class II classification with special controls was suitable, issuing the classification on June 6, 2014. Auxogyn’s Eeva System received FDA clearance at the same time.

The test, which is based on technology licensed from Stanford University, is designed to automatically analyze embryo development against scientifically derived cell-division timing parameters captured through continual video imaging. The data helps clinicians select the embryos best suited for IVF procedures.

The Eeva System also served as the impetus for
FDA's decision to classify assisted reproduction embryo image assessment technology as a Class II medical device with special controls. This includes devices such as the Eeva System that are used to analyze images to determine the development of embryos.

As part of the special controls, any company filing a 510(k) for an assisted reproduction embryo image assessment system must meet the special controls. These special controls include various testing, cleaning, and validation processes to ensure that the system does not result in possible harm, such as damage to the embryo, infection, inaccuracy, or user error.