July 2019 SaMD PreCert Update
We have been following the FDA's Software as Medical Device (SaMD) Pre-Cert pilot. The premise of...
Read MorePosted by William Hyman | Standards & Regulatory |
We have been following the FDA's Software as Medical Device (SaMD) Pre-Cert pilot. The premise of...
Read MorePosted by William Hyman | Standards & Regulatory |
Some of us remember when distributed medical devices such as patient monitors had their own...
Read MorePosted by William Hyman | Standards & Regulatory |
FDA has issued a request for SaMD developers to try out the PreCert excellence appraisal process....
Read MorePosted by William Hyman | Standards & Regulatory |
Recently the FDA released a discussion paper on a Proposed Regulatory Framework for Modifications...
Read MorePosted by William Hyman | Standards & Regulatory |
We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several...
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The FDA has released its plans for Final and Draft Guidance Documents for fiscal year 2019. ...
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...
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