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Innovative Devices to Get Speedier Review Under FDA Guidance

Dec. 18, 2018, 6:44 PM

The FDA offered medical device makers another option to get products on the market faster, promoting a “least-burdensome approach” to review innovative devices.

The Food and Drug Administration issued final guidance Dec. 18 on its Breakthrough Devices Program—which was established by the 21st Century Cures Act, a law enacted Dec. 13, 2016, to spur new drugs and devices.

FDA Commissioner Scott Gottlieb said makers of these breakthrough devices—or devices that offer new ways to treat or diagnose diseases or conditions—have earlier and more frequent engagement with the agency to spur the efficiency of the review process.

This is the FDA’s...

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