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
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
July 13, 2023
1
min read
LDTs and Oncology Companion Diagnostics Pilot Program – One More Step into FDA Regulating LDTs!
LDTs and Oncology Companion Diagnostics Pilot Program – One More Step into FDA Regulating LDTs!
June 29, 2023
5
min read
Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
June 22, 2023
2
min read
MHRA: Standalone Software and Apps
MHRA: Standalone Software and Apps
June 8, 2023
4
min read