FDA have issued a draft guidance\to help researchers and manufacturers design better quality trials.
The FDA wants the clinical studies to be in support of premarket approval (PMA) applications for medical devices, reports Medical News Today.
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 and setting appropriate study objectives.
Other recommendations include selecting the appropriate type of study, and choosing study sites and study participants.
It is one of 25 action items listed in the FDA's Plan of Action for Implementation of 510(k) and Science Recommendations, Medical News Today reports.
The FDA initiative was announced earlier this year to enhance predictability and transparency of regulatory pathways and to strengthen the 510(k) process.
Jeffrey Shuren, M.D. director of the FDA's Center for Devices and Radiological Health.said, "We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market.”
"This guidance will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials,” he said, reports Medical News Today reports.
“We encourage researchers to contact the FDA to discuss the most practical approach to studying their device,” said Shuren.
The evidence needed to support a PMA application varies depending on the medical device.
This draft guidance can help manufacturers and researchers design a pivotal study that is a practical investment of time, effort, and resources.
It is also hoped that future studies will demonstrate safety and effectiveness consistently.
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