Another Update to the FDA’s Pre-Certification Model
The FDA has released a January 2019 update to its working model of the precertification...
Read MorePosted by William Hyman | Standards & Regulatory |
The FDA has released a January 2019 update to its working model of the precertification...
Read MorePosted by William Hyman | Standards & Regulatory |
The 21st Century Cures Act of 2016 (Cures) had many provisions including defining what kinds of...
Read MorePosted by William Hyman | Standards & Regulatory |
Medical devices that contain software, or are software, are subject to the well-known medical...
Read MorePosted by William Hyman | Standards & Regulatory |
The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019. Â ...
Read MorePosted by William Hyman | Data Security, Standards & Regulatory, Uncategorized |
The Office of the Inspector General (OIG) of Health and Human Services (HHS) recently released a...
Read MorePosted by William Hyman | Standards & Regulatory, Strategy & Planning |
In June 2018 the FDA released an update to its working model of the Software Precertification...
Read MorePosted by William Hyman | Healthcare IT, Standards & Regulatory |
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously...
Read MorePosted by William Hyman | Mobile Health, Standards & Regulatory |
The impact of FDA's digital health Pre-Cert program has yet to be fully seen. There is much debate...
Read MorePosted by William Hyman | Regulatory Bibliography, Standards & Regulatory |
Since connectivity runs on software, and some medically related software is a medical device, and...
Read MorePosted by William Hyman | Regulatory Bibliography, Standards & Regulatory |
On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a...
Read More
Recent Comments