MEDIcept Insights
FDA Recognizes NEW Key Cybersecurity Standard
Introduction On November 7, 2023, FDA formally recognized a new cybersecurity standard titled ANSI AAMI SW96:2023 Standard for medical device security – Security risk management for device manufacturers [1]. This announcement comes after the standard was added to...
Five Major Principles for Predetermined Change Control Plans Regarding Machine Learning-Enabled Devices
On October 24th, 2023, U.S. Food and Drug Administration (FDA), Health Canada, and U.K Medicines and Healthcare products Regulatory Agency (MHRA) published 5 guidance principles for predetermined change control plans (PCCPs). These principles are designed to guide the...
Laboratory Developed Tests – FDA’s New Proposal
Introduction On September 29th, FDA announced a proposed rule regarding Laboratory Developed Tests (LDTs). LDTs are IVDs that are designed, developed, and used within a single laboratory. This new rule aims to improve the safety and effectiveness of these tests by...
FDA’s New Breakpoints in Device Labeling
Introduction to the Guidance FDA issued a new guidance document “Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling”. The purpose of this guidance document, issued on September 29, 2023, is to inform industry of the...
Understanding FDA’s NEW Draft Guidance on the De Novo eSTAR Program
While the FDA has issued extensive guidance to outline premarket submission requirements and relevant acceptance criteria, manufacturer discretion in the implementation of these requirements often results in a lack of uniformity in the way submissions are prepared and...
FDA’s NEW Final Guidance on the Breakthrough Devices Program
On September 15th, 2023, the FDA issued an updated final guidance on the Breakthrough Devices Program. As established by section 515B of the Federal Food, Drug, and Cosmetic Act, the Breakthrough Devices Program is intended to expedite the development and review of...