FDA - Unusual Letter Sent To iPhone-Based Testing Device Co

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product:

"(FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency."  . . .

"Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter."

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Is FDA Watching Over Cell Phones as Medical Devices?

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Updated March 24, 2021

People also search for the:

Digital Health Center of Excellence - FDA.gov

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Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.

In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.  

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iBreath - A Breathalyzer For Your iPod or iPhone

Way cool! Now you can connect an alcohol breathalyzer to your iPod or iPhone, reports this LA Times news article, "Blow into the iBreath and your iPod plays a blood-alcohol alert. Measure your blood alcohol level, and avoid driving while you're drunk. For about $80, you buy the iBreath from David Steele.com. How would you use the iBreath?

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