FDA to modernize medical device approval process: 5 things to know

The FDA plans to revamp how it clears medical devices through an expedited approval process called the 510(k) pathway, FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health, announced in a Nov. 26 statement.

Here are five things to know:

1. The 510(k) pathway, launched in 1976, is the most common way devicemakers bring their products to market. In 2017, the FDA cleared 3,173 devices via this pathway, which represents 82 percent of all devices the agency cleared or approved last year, according to the FDA leaders' joint statement.

2. The 510(k) process allows companies to seek an expedited approval process if they can prove their device is "substantially equivalent" to one already on the market, known as a predicate device.

3. Almost 20 percent of current devices cleared through the 510(k) pathway are based on a predicate that's more than a decade old, according to Drs. Gottlieb and Shuren.

4. The FDA wants to retire some of these predicate devices and make it easier for device companies to establish new ones. The agency may also list which devices are based on older predicates on its website to encourage devicemakers to base products off newer devices.

"We believe firmly in the merits of the 510(k) process," Drs. Gottlieb and Shuren wrote in their joint statement. "But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices."

5. Dr. Gottlieb called the changes "the most significant modernization of the 510(k) medical device review process in a generation" in a Nov. 26 tweet. The FDA plans to finalize guidance on creating an alternative 510(k) pathway in early 2019.

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