This report originally appeared in the November 2010 issue of DOTmed Business News

On the eve of the U.S. Food and Drug Administration’s 510(k) reform, industry fears the agency will keep life-saving products off the shelves, while consumer advocates worry the latest changes don’t do enough to protect patients.

After two years plagued by scandal, the FDA’s device division is now looking to toughen its 510(k) process, a clearance process used for tens of thousands of supposedly lesser-risk medical devices.

But as the division, known as the Center for Devices and Radiological Health, prepares to overhaul the nearly 35-year-old process, the agency faces a choice. In essence, it has to decide what sort of mistake it wants to make.

“We have an old, old tension here between which type of error or injury the FDA is willing to risk,” Walter Olson, a scholar with the libertarian think-tank the Cato Institute, told DOTmed News.

While the reform is driven partly by fears that slack regulation has allowed shoddy or untested devices to enter the market, overly burdensome regulations carry a risk of their own, even if it can be harder to quantify. A proliferation of red tape, costly to cut through, could scare away potential innovators, leaving life-saving products off U.S. shelves.

The need to balance innovation and safety was recognized early by the agency. In the 1970s, David Link, the chief of the Bureau of Medical Devices, the precursor to the FDA’s current device regulating section, noted this when he said he thought too many agency people were antagonistic to industry.

“[We] recognize that the bureau had the responsibility to get safe and effective products to the market as much as it was to keep unsafe and ineffective products off the market,” he said in a statement posted on the FDA website.

‘Fast-track’ process under review
At issue is a commonly used process for approving medical devices sometimes dubbed the “fast-track” process, as clearance usually takes less than three months.

This 510(k) process applies to most moderate-risk, Class 2 devices that are “substantially equivalent” to devices currently on the market, called “predicate” devices. The category, borne out of 1976 legislation, covers everything from relatively low-tech motorized wheelchairs to state-of-the-art MRI scanners.

Very low-risk products, like tongue depressors, fall under the Class 1 category. They, and even some Class 2 devices, are exempt from the 510(k) process. The riskiest devices, such as pacemakers, come under the much tougher Class 3 rules, which generally require a premarket application (or PMA), often involving extensive and expensive clinical trials.

More Industry Headlines