SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ — The
FDA today issued draft guidance to help researchers and
manufacturers design better quality clinical studies in support of
premarket approval (PMA) applications for medical devices.
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 FDA’s 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, said Jeffrey Shuren, M.D., director of the FDA’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
The evidence needed to support a PMA application varies
depending on the medical device. But today’s draft guidance can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.