Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices
Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices
October 30, 2023
4
min read
Laboratory Developed Tests – FDA’s New Proposal
Laboratory Developed Tests – FDA’s New Proposal
October 17, 2023
4
min read
FDA’s New Breakpoints in Device Labeling
FDA’s New Breakpoints in Device Labeling
October 13, 2023
3
min read
Understanding FDA’s NEW Draft Guidance on the De Novo eSTAR Program
Understanding FDA’s NEW Draft Guidance on the De Novo eSTAR Program
October 11, 2023
4
min read
FDA’s NEW Final Guidance on the Breakthrough Devices Program
FDA’s NEW Final Guidance on the Breakthrough Devices Program
October 4, 2023
5
min read
NEW FDA Guidance on Human Factors Engineering for Combination Products!
NEW FDA Guidance on Human Factors Engineering for Combination Products!
September 25, 2023
5
min read
FDA’s NEW Final Guidance on Use of ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
FDA’s NEW Final Guidance on Use of ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
September 13, 2023
4
min read
Is Your Product a Medical Device or a Borderline Product?
Is Your Product a Medical Device or a Borderline Product?
July 25, 2023
2
min read
FDA Updates Their CLIA Waiver Process
FDA Updates Their CLIA Waiver Process
July 20, 2023
1
min read