Tag Archives: CDRH

FDA Unveils Vision for National Post-Market Device Surveillance

By MedTech Intelligence Staff
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A recent report describes an ambitious national medical device monitoring system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.

A recent report describes an ambitious national medical device monitoring system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.

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FDA’s Single Audit Program Invites Participants

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.

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Apps: Fun or Medical Devices?

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.

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