The FDA has updated their CLIA Waiver Process in the following ways: CLIA Waiver by Application The FDA has updated its CLIA waiver process to provide manufacturers of in vitro diagnostic (IVD) tests with clearer guidelines and requirements. Under the Clinical...
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...
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...
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...
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...
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...
On May 2, 2023, FDA published a draft guidance for Decentralized Clinical Trials for Drugs, Biological Products, and Devices – Guidance for Industry, Investigators and Other StakeHolders. In this draft guidance, the FDA states that “regulatory requirements for...
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...
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...
On March 2nd, 2023, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published a guidance, “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS). The same day the White House published its...