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...
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...
