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

Becker's Healthcare November 26, 2018
Mackenzie Bean

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...

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