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...
Read More
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...
Read More
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...
Read More
FDA Busy With Software
Since connectivity runs on software, and some medically related software is a medical device, and...
Read More
FDA Guidance on Software Changes
On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a...
Read More
Even More Proposed Medical Device Connectivity Legislation
The FDA, medical devices, and cybersecurity are popular subject matter for proposed Federal...
Read More
FDA to Address Cybersecurity at Workshop
Cybersecurity continues to be a hot topic in healthcare with several areas of concern. These...
Read More
Sussing Out SaMD — Software as a Medical Device
Software as a Medical Device (SaMD) is terminology under the aegis of a work group of...
Read More
When Does Regulated Software Need a New 510(k)?
A ubiquitous characteristic of software is that it often undergoes numerous changes after it is...
Read More
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....
Read More
Recent Comments