MEDIcept Insights
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
The Breakthrough Devices Program is consistent with the FDA’s mission to protect and promote public health by helping, through a prioritized review, expedite the development, assessment, and review of a device all while considering statutory standards. The voluntary...
LDTs and Oncology Companion Diagnostics Pilot Program – One More Step into FDA Regulating LDTs!
Introduction While many common laboratory tests are commercial tests, manufactured and marketed to multiple labs, some tests are designed, manufactured, and used within a single laboratory. These tests, called “laboratory-developed tests” or “LDTs” are supposed to be...
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On May 2, 2023, FDA published a draft guidance for Decentralized Clinical Trials for Drugs, Biological Products, and Devices – Guidance for Industry, Investigators and Other StakeHolders. In this draft guidance, the FDA states that “regulatory requirements for...