Female enrollment in PMA trials will be addressed in FDA guidance.

ENROLLMENT OF WOMEN IN PMA STUDIES WILL BE ADDRESSED IN FDA GUIDANCE under development within the device center's Office of Device Evaluation, according to agency staffers. The guidance is being developed in response to a March 1 report from the device center's internal working group on women's health issues that concluded that the agency should "develop clinical protocol guidance that requires appropriate enrollment of both genders" in trials to support premarket approval applications.