regulatory

23andMe’s 510(k) May Help Develop Regulatory Pathway for mHealth

By seeking a de novo 510(k) clearance from FDA, 23andMe may be leading the way in developing a straightforward, hopefully low cost, low burden regulatory pathway.
The 510(k) process is…

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Cybersecurity and Medical Devices

An article in the Journal PLoS reports that medical devices that rely on wireless technology to transmit data could be vulnerable to cyber attacks and urges improved federal monitoring of…

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Happtique Seeking Comments on Draft Standards for Apps

Happtique, a mobile health app store, has released a draft of the standards it will use to certify medical, health, and fitness apps. The program will allow Happtique to rate…

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