FDA Says It Will Overhaul Long-Criticized System for Approving Medical Devices

U.S. health officials said earlier this week they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and related products.

The Food and Drug Administration (FDA) announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients.

The FDA’s move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations. Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the FDA over a 10-year period.

“We believe that it’s time to fundamentally modernize an approach first adopted in 1976,” said FDA Commissioner Scott Gottlieb in a statement, noting that the changes under consideration would push companies to compare their devices to more up-to-date technology.

On Twitter, he described the proposal as “the most significant modernization” of the medical device review process in a generation.

Some of the reforms proposed by the FDA could take years to implement and potentially include new guidelines and regulations for manufacturers, and the most substantive changes could require action by Congress.

Dr. David Challoner, a leading expert on the FDA’s review system, said the changes would likely improve device safety, but he worried manufacturers could scuttle the reform effort.

“If the device industry comes back at this full bore with their lobbying efforts, this could all die a slow and painful death,” he said.

In 2011, Challoner led a government advisory panel that recommended the FDA’s “flawed” review system be replaced. At the time, the FDA said it disagreed with the group’s recommendations.

The FDA’s framework for clearing more than 95 percent of devices on the U.S. market has long been criticized in reports from government watchdogs and independent medical experts. Unlike new pharmaceuticals — which are tested in patient studies — most medical devices only have to show that they are similar to devices already on the market. Only a handful of truly new devices must undergo extensive clinical testing to verify they are safe and effective.

Challoner’s review panel had concluded that Congress originally intended for the streamlined pathway to be a temporary way to “grandfather” in thousands of low-to-moderate risk devices then on the market. But instead of being phased out it became the principal approval path.

Defective devices cleared through the streamlined system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding, and a surgical instrument that inadvertently spread uterine cancer.

As generations of devices have been cleared via the FDA’s main review process, medical products have become increasingly complex and often barely resemble the decades-old “predicates” they claim to reference. Devices cleared through this system, known as the 510(k), include imaging scanners, computerized drug pumps, artificial joints and spinal implants.

The FDA said it would consider phasing out some older devices so that new products could no longer reference them to enter the market. The agency noted that nearly 20 percent of devices cleared through its main review process are predicated on devices that are more than 10 years old.

The Advanced Medical Technology Association, the industry’s chief lobbying group, said in a statement that it looked forward to learning more about the FDA’s plans.

“While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved,” the group said.