FDA Moves Toward Reduced PMA Requirements For Medical Devices
By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. Food and Drug Administration (FDA) will use data from previous randomized clinical trials (RCTs) to help device developers design less cumbersome studies of global endometrial ablation (GEA) devices for future premarket approval (PMA) applications. FDA considers this a step toward overall streamlining of medical device clinical trials.
Since previous RCTs of five FDA-approved GEA devices shared similar characteristics, the FDA sought to "leverage the RCT data to help support a less burdensome clinical trial design for future premarket approval applications for GEA devices," according to an FDA Voice blog post. "With input from industry and members of the FDA Obstetrics and Gynecology Devices Advisory Panel, the FDA was able to apply a statistical analysis model, called an objective performance criterion (OPC), to determine the minimum acceptable success rate for demonstrating device effectiveness."
The FDA, which says it will publish more details about the OPC soon, claims the OPC will streamline the design and conduct of GEA clinical trials by not requiring control groups. Future studies also will require fewer participants and fewer resources to run.
According to an FDA guidance, "An OPC is a numerical target value derived from historical data from clinical studies and/or registries which may be use for comparison with safety or effectiveness endpoints" and is "usually a very well-described and publicly available control used to set the criterion."
There have been very few OPCs since device technology needs to be fairly mature, according to the document. Devices which have been measured using OPC include intraocular lenses and heart valves. GEA devices will be the latest products to utilize OPCs to speed up FDA reviews.
The FDA has been emphasizing its efforts to streamline clinical trials to encourage manufacturers to conduct studies in the United States and to make their products available quicker to patients living in the country. For example, the FDA granted early approval to Medtronic's TAVR CoreValve system — for patients with severe aortic stenosis who are at high risk for surgery — without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial.
The FDA's Center for Devices and Radiological Health (CDRH) considers facilitating clinical trials as a strategic priority. It has introduced new guidance on investigational device exemptions (IDEs) to allow earlier and more efficient clinical study enrollment, as well as participated in collaborative projects such as the Medical Device Innovation Consortium’s Clinical Trial Innovation and Reform Project.
"Through strengthening the clinical trial enterprise, we hope to encourage manufacturers to study new and important medical devices in the U.S., helping us fulfill our vision of providing patients with high-quality, safe and effective medical devices of public health importance first in the world," wrote Ben Fisher, Ph.D., FDA Director, Division of Reproductive, Gastro-Renal, and Urological Devices, Office of Device Evaluation at the CDRH, in the blog post.