July 2019 SaMD PreCert Update
We have been following the FDA's Software as Medical Device (SaMD) Pre-Cert pilot. The premise of...
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Category: Standards & Regulatory
Are We Over Connected Yet?
Some of us remember when distributed medical devices such as patient monitors had their own...
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FDA Seeks SaMD PreCert Mock Applicants
FDA has issued a request for SaMD developers to try out the PreCert excellence appraisal process....
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FDA on Modifying AI
Recently the FDA released a discussion paper on a Proposed Regulatory Framework for Modifications...
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ONC Finds Possible Merit in FDA Pre-Cert
We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several...
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Another Update to the FDA’s Pre-Certification Model
The FDA has released a January 2019 update to its working model of the precertification...
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FDA on Software That Isn’t a Medical Device
The 21st Century Cures Act of 2016 (Cures) had many provisions including defining what kinds of...
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FDA to Divide Cybersecurity Risk Into Two Tiers
Medical devices that contain software, or are software, are subject to the well-known medical...
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Managing Digital Health Regulatory Uncertainty
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and...
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FDA’s Guidance Plans for Software in FY 2019
The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019. ...
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HHS OIG on Cybersecurity and the FDA
The Office of the Inspector General (OIG) of Health and Human Services (HHS) recently released a...
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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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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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