MEDIcept Insights
Understanding the Essentials of Clinical Investigation Under the EU Medical Devices Regulation (MDR): Insights from MDCG 2021-6 Update
In the realm of medical devices, the European Union’s Medical Devices Regulation (MDR) stands as a cornerstone, ensuring that devices are rigorously evaluated for safety and effectiveness. The recent update to the Medical Device Coordination Group’s (MDCG) guidance -...
Understanding FDA’s Guidance on Medical Device Export Certificates
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...
Managing Legacy Medical Device Cybersecurity Risks- What You Need to Know!
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...
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...