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Manufacturers submit PMA applications for high-risk (class III) medical devices. These applications undergo the most stringent type of FDA device review. PMA submissions include data from pivotal clinical studies which the FDA uses, along with other information, in determining approval.
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.
It is one of 25 action items listed in the FDAs Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to enhance predictability and transparency of regulatory pathways and to strengthen the 510(k) process.
"We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market, says Jeffrey Shuren, MD, director of the FDAs Center for Devices and Radiological Health. "This guidance will help manufacturers and researchers better understand the FDAs basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device."
The evidence needed to support a PMA application varies depending on the medical device. But todays draft guidance can help manufacturers and researchers design a pivotal study that is a practical investment of time, effort, and resources and has a high likelihood of demonstrating safety and effectiveness.
Although this guidance is developed primarily for clinical studies used to support PMAs, the recommendations of this guidance may also be used in designing clinical studies used to support 510(k) submissions.