Friday, July 24, 2009

Is FDA Watching Over Cell Phones as Medical Devices?

This driver is using two phones at onceImage via Wikipedia

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.

Related Articles and Previous Posts:
FDA may regulate certain mobile phones, accessories
Avoid FDA 510k Medical Device Clearance Mistakes - 5 Free Tips
The Medical Device Safety Act of 2009
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
Nice Review of US FDA Medical Device Regulation
FDA 510(k) Free Tips And Pearls Of Wisdom

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