The US Food and Drug Administration's (FDA) device regulatory division wants to know: Are medical devices meeting the unique needs of women?
That question is behind a newly announced workshop the agency's Center for Devices and Radiological Health (CDRH) plans to hold in June 2013 entitled, "The Health of Women (HoW) Program: Educate, Enable, Enlist and Explore-HoW to Improve the Health of Women."
FDA has in the last two years announced at least one initiative in response to what it says is the "historic underrepresentation of women in clinical studies."
That initiative, found in the form of a draft guidance document entitled Evaluation of Sex Differences in Medical Device Clinical Studies, "is intended to provide guidance for the design and conduct of clinical studies to improve information about the safety and effectiveness of new medical devices in women when approved by the FDA," the agency wrote.
The additional information is necessary, it said, because certain medical products promote different responses in women than in men. FDA's draft guidance notes that some of these factors are intrinsic-genetics, hormones, body size and physiology-while others are rooted in culture and the environment. Unlike men, women may also have to pay special attention to the teratogenicity of a product, which could cause birth defects to an unborn child.
At issue, then, is whether regulators can reasonably assure patients that a device is safe and effective for use, regardless of the patient's sex.
HoW to Proceed?
That's where the HoW program comes in, FDA said.
CDRH said it hopes that the program can bring together various stakeholder groups-industry, clinicians, researchers, academia, government and patients-to address at least four primary concerns: How to recruit and retain women for device clinical trials, how to improve analysis and communication of sex-specific findings of studies to patients and providers, how to meet the unmet needs of women, and how to foster the development of new strategies, technologies and clinical study paradigms.
The hope, FDA said, it that the agency will be able to develop a "priority research road map for the HoW device ecosystem" that will in turn allow it to address some of the "unique issues in the regulation of medical devices for use by women."
Topics for the workshop may be submitted to FDA until 31 July 2013, and the workshop will occur on 24-25 June 2013 at FDA's White Oak Campus in Silver Spring, MD. The meeting will be streamed online for those unable to attend.