Makers of medical devices should address a "historic underrepresentation" of women in clinical studies by improving the quality of gender-specific data they collect, the U.S. Food and Drug Administration said.
FDA draft guidelines issued Friday note that certain devices trigger different responses in women than in men due to factors such as genetics, hormones, body size and diet.
The guidelines call on companies "to enroll representative proportions of both women and men in their device studies."
The FDA cited a 2001 Government Accountability Office study on drug trials that found 30 percent of study documents didn't report outcomes by gender, even though women accounted for 52 percent of enrollees.
One device maker, Little Canada-based St. Jude Medical, said in a statement that it supports efforts to improve transparency on gender differences among study results. "Women are still often undertreated for a number of conditions," St. Jude said.
