Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
As software and technology continues to advance at a rapid pace, the healthcare industry has witnessed a significant transformation in the way medical devices are regulated and approved. In recent years, both the United Kingdom's Medicines and Healthcare products...
MHRA: Standalone Software and Apps
The Medicines and Healthcare Products Regulatory Agency (MHRA) guidance document: Medical device stand-alone software including apps (including IVDMDs) serves as a replacement for the previous MHRA guidance on medical device standalone software and apps. It...
Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices
The Food and Drug Administration (FDA) is actively exploring the use of artificial intelligence (AI) and machine learning (ML) in drug development and medical device creation. In collaboration with various centers, including the Center for Drug Evaluation and Research...
FDA’s New Clinical Trial Guidance Allows you to Streamline!
On May 2, 2023, FDA published a draft guidance for Decentralized Clinical Trials for Drugs, Biological Products, and Devices – Guidance for Industry, Investigators and Other StakeHolders. In this draft guidance, the FDA states that “regulatory requirements for...
FDA “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” Clinical Insight Paper
Introducing the game-changer in clinical investigations: The FDA has just released their highly anticipated guidance document on A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry in April 2023. This...
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act
A “cyber device" is a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed, or...