rangani_rj
Involved In Discussions
Hi All,
FDA just published this final guidance. It identifies and addresses those issues to be considered during clinical studies to gain sex based difference in clinical outcome of medical device i.e. Barriers to enrollment of women, recommendations, statistical consideration, poolability of data etc.
Because of hormonal (and so physiological) differences, certain devices work differently in male and female i.e. (as given in guidance)
1. Ventricular Assist Devices (VADs): A higher rate of stroke (18% vs. 6%), bleeding and infection found in women as compared to men.
2. Cardiac Resynchronization Therapy Defibrillators (CRT-D): CRT-D therapy more effective in woman over ICD (77% versus 42% in man).
3. Total hip replacement (THR) revision surgery: Revision surgeries in THR are to be required for patients feeling discomfort after few years (due to wear and tear of devices or detachment of implant from bone). Rate of revision surgery is higher in among women (19.8% vs 14.6% in man).
Decision framework is provided at the end of document.
Guidance is meant for devices used in both genders, not for devices exclusively used in female i.e. Gynecology/obstetric products, which are obviously tested on female patients.
FDA just published this final guidance. It identifies and addresses those issues to be considered during clinical studies to gain sex based difference in clinical outcome of medical device i.e. Barriers to enrollment of women, recommendations, statistical consideration, poolability of data etc.
Because of hormonal (and so physiological) differences, certain devices work differently in male and female i.e. (as given in guidance)
1. Ventricular Assist Devices (VADs): A higher rate of stroke (18% vs. 6%), bleeding and infection found in women as compared to men.
2. Cardiac Resynchronization Therapy Defibrillators (CRT-D): CRT-D therapy more effective in woman over ICD (77% versus 42% in man).
3. Total hip replacement (THR) revision surgery: Revision surgeries in THR are to be required for patients feeling discomfort after few years (due to wear and tear of devices or detachment of implant from bone). Rate of revision surgery is higher in among women (19.8% vs 14.6% in man).
Decision framework is provided at the end of document.
Guidance is meant for devices used in both genders, not for devices exclusively used in female i.e. Gynecology/obstetric products, which are obviously tested on female patients.