The FDA has released a new proposed plan to improve medical device safety for women.
The agency’s Center for Devices and Radiological Health (CDRH) said today that the proposed strategic plan will address sex- and gender-specific issues in medtech design, development, clinical trial design and other medical device-related matters.
The strategic plan is part of 2016 CDRH’s Health of Women program, designed to consider a woman’s entire body — not just her reproductive system.