Seeking to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices, the FDA has issued a draft guidance. The agency welcomes comments for the next 90 days.
The proposed guidance outlines agency expectations for clinical trial design issues such as minimizing data bias and variability, setting appropriate study objectives, selecting the appropriate type of study, and choosing study sites and study participants.
“We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market,” said Jeffrey Shuren, MD, director of the US Food and Drug Administration’s Center for Devices and Radiological Health. “This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device.”