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Classified: Next-Gen Sequencing Analyzers, Mobile Glucose Monitoring, Restless-Leg Devices

 
• By David Filmore

FDA issued orders officially finalizing regulatory classifications and special controls for next-generation sequencing analyzers; "secondary display" devices for continuous glucose monitor data; and vibratory counter-stimulation devices for restless leg syndrome. And the agency is working towards formalizing 510(k) exemptions for future devices of these types as well.

Three significant de novo classifications from the past several years were made official this week by US FDA. The agency issued orders designating high-throughput next-generation sequencing analyzers, "secondary displays" for continuous glucose meters, and vibratory counter-stimulation devices into class II with special controls.

FDA handed down the positive de novo decisions in 2013 and 2015, but the March 14 orders formally record the new class II device types and the marketing standards for...

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More from Device Area

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

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• By Natasha Barrow

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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.