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FDA looking into real-world evidence for device evaluation

Shared by Radhika Narayanan | 0 321 1 | about 3 years ago

When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show how something truly operates in everyday life. But, according to a panel at the Connected Health conference in Washington, D.C, digital health tools that generate a trove of data could put us on shorter paths to regulatory clearance, albeit with some challenges.

Read More On www.mobihealthnews.com

Categories FDA Medtech & Devices

Links

http://www.mobihealthnews.com/content/fda-looking-real-world-evidence-device-evaluation
http://www.mobihealthnews.stfi.re/content/fda-looking-real-world-evidence-device-evaluation?sf=lwadwxx
http://stfi.re/lwadwxx
http://bit.ly/2hukkr7

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