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The U.S. Food and Drug Administration (FDA) has announced (May 6) that the Office of Inspections and Investigations (OII) will expand its program (pilot) of unannounced inspections beyond India and China. As we reported earlier this year, the FDA has the authority to perform both announced and unannounced inspections. In general, inspections of relevant entities in the U.S. have been unannounced..

We reported in August of 2024, about the publication of a revised draft of the Mexican Standard for Good Manufacturing Practices for Medical Devices, titled PROY-NOM-241-SSA1-2024. In Mexico, a Norma Oficial Mexicana (Official Mexican Standard, NOM), is compulsory. We discussed some of the notable changes proposed by COFEPRIS in contrast with the previous 2021 version of the standard, subject to..

The 2025 International Symposium on Human Factors and Ergonomics in Health Care was held in Toronto and included upwards of 700 attendees across the 4-day program, including a day specifically dedicated to the second annual Healthcare Robotics Summit. The summit was a huge success, bringing together human factors practitioners, researchers, students and clinicians in a collaborative environment ..

The U.S. Food and Drug Administration (FDA) has opened the test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) in preparation for the official launch at 9:00 a.m. ET on April 14, 2025. The testing phase will conclude after April 11, and the existing (legacy ESG) system will be disabled at midnight Eastern time (ET) on April 12. No submissions can be made i..

Introduction to the EUDAMED Workshop The European Commission is organising a free registration hybrid workshop in Stuttgart to support the EUDAMED onboarding of all concerned actors, in view of the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules of the system. The workshop will provide an overview of the obligations under the Medical Devices..

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..

The first three months of 2025 have ended and our team has been ardently sharing regulatory news. No particular regulatory update was heralded as groundbreaking (other than news of an agreement between the Malaysia Medical Device Authority (MDA) and China NMPA to ease regulatory requirements for certain classes of devices). Progress from the International Medical Device Regulators Forum (IMDRF) ..

Court decision on LDTsOn March 31, 2025, the US District Court (Eastern District of Texas, Sherman Division) ruled that the FDA’s Final Rule on Laboratory Developed Tests (LDTs) published in 2024, which phases out enforcement discretion and phases in standard medical device requirements, be vacated and set aside. This court determined that Congress has vested authority of test services to the Ce..

As Notified Bodies (NBs) in the European Union (EU) begin to roll out Article 16(4)  of the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)  certification schemes, we at Emergo by UL share our insights on the requirements set out in Article 16 and their applicability to importers, distributors and other natural or ..

Addressing potential usability issues early in the human factors engineering (HFE) process can save your team time and money over the course of development while providing evidence of a robust human factors process to regulatory agencies. Cognitive walkthroughs are a powerful method to identify potential usability issues in early development stages when initial decisions about design directions ..