FDA May Seek More Authority From Congress in Device Approval Process

The U.S. Food and Drug Administration (FDA) said Thursday during an all-day public hearing on the 510(k) medical device approval process that it may need to go to Congress for more authority.

Agency officials said the agency has limited authority to recall medical devices on the market and can’t adequately oversee how device makers label their products. In addition, they said the FDA has limited power over medical device once they are on the market. The FDA has commissioned a review by the Institutes of Medicine and is conducting its own internal investigation.

“Developing clear definitions, guidance and additional authorities may be required,” said Heather Rosecrans, director of the FDA office that oversees such reviews.

Dr. Jeffrey Shuren, head of the FDA’s device division, Center for Devices and Radiological Health, said the best thing the agency can do is “look under the hood…and see what the root causes are,” he said.

Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association, said in a statement: “The 510(k) process provides strong protections to American patients and promotes medical innovation. It gives FDA the flexibility it needs to ensure the safety and effectiveness of incremental changes made to low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices. While the basic structure of the 510(k) process works very well and has evolved over time to better meet the needs of American patients, we recognize that there is no process that cannot be improved.”

The FDA’s task force will make its recommendations public in June.