10 Changes to the FDA’s Pre-Cert Program Model
In June 2018 the FDA released an update to its working model of the Software Precertification...
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Author: William Hyman
Ranking the Importance of SaMD — Software as a Medical Device (UPDATE)
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously...
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Will Pre-Cert Increase the Advantage of Big Companies? (UPDATE)
The impact of FDA's digital health Pre-Cert program has yet to be fully seen. There is much debate...
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FDA Busy With Software
Since connectivity runs on software, and some medically related software is a medical device, and...
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FDA Guidance on Software Changes
On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a...
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Even More Proposed Medical Device Connectivity Legislation
The FDA, medical devices, and cybersecurity are popular subject matter for proposed Federal...
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FDA to Address Cybersecurity at Workshop
Cybersecurity continues to be a hot topic in healthcare with several areas of concern. These...
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Sussing Out SaMD — Software as a Medical Device
Software as a Medical Device (SaMD) is terminology under the aegis of a work group of...
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When Does Regulated Software Need a New 510(k)?
A ubiquitous characteristic of software is that it often undergoes numerous changes after it is...
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Advice from the FDA on Medical Device Data Sharing
Among the many forms of data flow that might occur from a medical device is direct to the patient....
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