Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical outcome is related not only to the genetic variance but also to the sex of the patient.
The Food and Drug Administration (FDA) recently issued a new guidance for industry and FDA staff that may be relevant in the design and development of medical devices that serve personalized medicine, especially those that categorize patients into responders and non-responders. “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” (Guidance) should be carefully reviewed by clinical device manufacturers, especially manufacturers of devices that separate individuals into two or more groups, such as those that respond to a particular treatment and those that do not respond. The Guidance is intended for devices that require clinical information in support of a marketing submission, whether a premarket notification (510(k)), premarket approval (PMA), a de novo request, or a humanitarian device exemption application. The recommendations reported in the Guidance also apply to post-approval study submissions and postmarket surveillance. Continue reading this entry