The U.S. Food and Drug Administration (FDA) officials have indicated they face difficulties in reviewing certain medical devices.
According to a report filed by Dow Jones, the FDA comments came as part of a meeting where government officials and mostly industry representatives from companies such as Medtronic discussed ways to possibly alter and strengthen its medical-device approval process.
The focus was on a FDA approval system for moderate-risk devices such as orthopedic knee and hip replacements. The agency said that this system is open to abuse and wants to revamp it. The approval process, called 510k, is used when a company wants to sell a new device that is based on a product already on the market.
The agency staff said it is difficult to weigh new products under the accelerated review process used for products similar to those already approved, reported Reuters. It can be hard to tell if a new device is truly similar to an approved product or if there are enough differences to classify it as an entirely new product, they said. Difficulty inspecting devicemakers and a high number of proposed new products are also an issue.
“Developing clear definitions, guidance and additional authorities may be required,” said Heather Rosecrans, director of the FDA office that oversees such reviews, known as 510(k).
It has already emerged that the FDA may tighten or eliminate several pathways for getting a medical device approved quickly amid concerns they have been overused by industry.
The 510(k) system is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing. About 3,500 devices are cleared every year under the 510(k) system.
