A study of 82 trials supporting FDA premarket approval of medical devices in 2015 showed 4% of the studies evaluated product safety and effectiveness by race, while 9% performed analysis by age and 17% by gender. Authors of the study in JAMA Internal Medicine suggest that trial enrollment of minorities, women and the elderly in proportions used by the product's target population could be required through changes to the Medical Device User Fee Amendments.
Study examines demographic-specific data inclusion in device trials
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