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FDA’s 2018 Cybersecurity Guidance Overview
Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA...
FDA Announces Medical Device Reporting Changes
The US medical device regulating authority, the FDA, terminated the Alternative Summary Reporting Program, used for reporting for over 10 years. Medical device manufacturers exempted from reporting were informed that...
The Current Regulations of Mobile Health
Mobile phones have become such an influential factor of our daily lives that it is almost a necessity for us.  It provides efficient solutions to many tasks such as banking, shopping, and much more. With its such...
Future of AI/ML-Based SaMD and the Application
The US medical regulating authority (FDA) finished the discussion on recently published framework for Software as a Medical Device (SaMD) to create a basic guidelines for innovative technologies such as artificial...