This article is more than 5 years old. Information may no longer be current.
FDA official: Agency working to balance regulation, facilitation roles
Click Here to Manage Email Alerts
 Jeffrey Shuren |
The FDA is taking steps to more effectively manage pre-market programs, an agency official told a U.S. Senate panel.
“We realize that FDA should help to create a regulatory environment that allows innovation to thrive by eliminating undue regulatory obstacles while also assuring consumer confidence that our medical technologies are safe and effective,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated in a news release.
In the past, Shuren said, the FDA’s insufficient predictability led to inefficiencies, higher costs and delays. The root causes tended to be high employee turnover, lack of reviewer training, too many supervisors and not enough reviewers, increasing workload, and unnecessary or inconsistent requirements imposed on device companies, he said.
Another issue leading to regulatory delays was the poor quality of some submissions from device manufacturers, Shuren said.
“We do need to work with industry ... on ensuring we’re getting quality submissions,” he stated. “We’re working on criteria for when we would not accept an application.”
Overall, Dr. Shuren defended the FDA process as superior to the speedier programs in place in the European Union, specifically calling attention to devices that were approved for use in Europe then subsequently removed from the market after FDA trials demonstrated issues with safety or efficacy.
“We think the U.S. standard is the right standard,” Shuren stated. “But what we need to do is to assure there is timely access to devices that are, in fact, safe and effective, and the steps we’re taking are trying to get there.”