By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Emergo Group
FDA updates final guidance on ISO 10993 for medical device biocompatibility
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices. The updated guidance replaces guidance the agency had finalized in 2016 that emphasized biological evaluations in conjunction with risk management considerations for […]
India regulators propose medical device, IVD extensive risk classification lists
By Stewart Eisenhart, Emergo Group Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products in order to clarify regulatory pathways and requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
U.K. regulators issue new post-Brexit medical device regulatory compliance guidance
By Evangeline Loh and Ronald Boumans, Emergo Group The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain (and Northern Ireland and European Union (EU)) starting January 1, 2021. This is of course in the event of an anticipated hard Brexit. Get […]
Understanding clinical evidence requirements under European Medical Devices Regulation
By Dietmar Falke, Emergo Group The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing […]
FDA medical device user fees to increase 7% in 2021
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans a 7% medical device user fee increases for the 2021 fiscal year, raising costs slightly for premarket submissions including 510(k) Premarket Notifications, Premarket Authorizations (PMA) and De Novo requests for classification. Get the full story here at the Emergo Group’s blog. The opinions […]
FDA announces new Class II medical device 510(k) exemptions
By Timothy Herr, Emergo Group The US Food and Drug Administration (FDA) published a final order listing categories of Class II medical devices that are now exempt from 510(k) premarket notification. The order also establishes new product codes and changes the title associated with one existing product code. Get the full story here at the […]
US FDA extends UDI deadlines for low-risk medical devices
By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration pushes back enforcement deadlines for certain Unique Device Identification (UDI) requirements for Class I and unclassified medical devices due partially to the agency’s coronavirus pandemic-related priorities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
China issues new procedures for medical device registration
By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its […]
How EU MDR and human factors affect design user-friendly software user interfaces
By Kimmy Ansems and Linda Giesselink, Emergo Group Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices. In the fourth blog post in our series on the European Medical Devices Regulation (MDR) and human factors engineering, we reference various MDR General […]
