Matthew Perrone, AP
Makers of medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year. The Food and Drug Administration has released recommendations designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective.
The FDA's report comes nearly a year after FDA's medical devices division endured a storm of criticism from public health advocates and lawmakers. Last August, the head of the device division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. Last year began with congressional investigators saying the FDA should take immediate steps to make sure more devices are reviewed through the most stringent process.
The recommendations come from two internal FDA panels that were tapped to draft changes in the wake of the outside criticism. The FDA is not bound by the reports, and will accept public comments for 90 days.
“Taken together, these preliminary reports show a smarter FDA, an agency that recognizes both sides of our mission to protect and promote public health,” said FDA devices chief Dr. Jeffrey Shuren. FDA's critics said the recommendations are a positive first step, but that they hoped for bolder action from regulators.
“The good news is that I think the agency is admitting there are loopholes in the system that have allowed products to be sold that aren't safe, the bad news is they haven't yet figured out what to do about it,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families.
At the center of the overhaul is the nearly 35-year-old system the FDA uses to grant speedy approval to devices that are deemed similar to products already on the market. The so-called 510(k) system is popular among manufacturers because it is a faster path to market than the review process for novel devices, which must undergo rigorous medical testing. Hip replacements and drug pumps are among the devices cleared under the system.
About 4,000 devices are cleared every year under the 510(k) system, while about 50 devices are approved under the more stringent system. But FDA critics say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny.
The FDA's panel recommends the agency clarify when a device is sufficiently similar to those already on the market to receive 510(k) clearance. The group also recommends that manufacturers be required to submit a summary of all available safety information about their device, instead of just the basic information required under current regulations. FDA officials said they would likely pursue other recommendations that would make it easier to revoke approval for devices on the market that appear unsafe or ineffective.
The FDA has rescind approval for about 100 devices cleared under the 510(k) system since 1976, but Shuren said a clearly defined rule would help the agency better police the industry.
Shuren said the changes should not affect the number of devices cleared by the FDA each year. Wall Street analysts have predicted companies will have to submit more data to win approval — taking a larger toll on their bottom lines. But industry observers note there are aspects of the proposal that could also smooth the regulatory process for companies. The FDA's panel suggests issuing regular guidance letters to update the industry on changing submission requirements for various devices.