Introduction “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices” outlined in this document navigates the regulatory landscape established by the FDA Reauthorization Act of 2017 (FDARA), particularly Section 704, and the...
Introduction The MITRE Corporation created the White Paper "Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks" in November 2023. While not official FDA guidance, it gathers insights from industry stakeholders, the FDA, and other government...
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...
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...
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...
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...
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...
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...
Introduction to the Final Guidance FDA recently published a final guidance document, “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.” This question-and-answer formatted document aims to clarify and provide...
Introduction to the Final Guidance On September 8, 2023, FDA issued the new final guidance “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".” The aim of this...