This week in medical device regulatory news, the FDA launched ESG NextGen, a modernized platform for secure electronic submissions that replaces the legacy WebTrader system; and Brazil’s Anvisa reclassified ultrasensitive CRP devices from Risk Class III to Class II, simplifying the regulatory pathway from registration to notification.
On April 23, 2025, the FDA unveiled the new Electronic Submission Gateway Next Generation (ESG NextGen), a modernized, web-based platform designed to streamline and secure electronic regulatory submissions. Replacing the legacy WebTrader interface, the Unified Submission Portal (USP) allows users to submit and track regulatory information with improved efficiency and user experience. The original ESG system is now fully retired. User guides and training resources are available to assist with the transition.
🔗 Electronic Submissions Gateway | FDA
Learn more about FDA US Medical Device Registration.
Anvisa has revised the health classification guidelines for medical devices that measure the ultrasensitive CRP (C-reactive protein) parameter. As a result of this change, these devices are now reclassified from Risk Class III to Risk Class II, meaning they are now subject to notification rather than full registration.
This update is based on Technical Note 17/2025/SEI/GEVIT/GGTPS/DIRE3/ANVISA and aligns with the provisions of Collegiate Board Resolution (RDC) 830/2023, which governs the notification and registration of in vitro diagnostic (IVD) medical devices.
Companies that have already submitted reclassification requests will be contacted by the In Vitro Diagnostic Products Management team with guidance on next steps. This also applies to any Class III registrations filed or granted during the current validity of RDC 830/2023.
For all new submissions related to ultrasensitive CRP tests, the revised Risk Class II should be applied, reflecting their updated status as notification-based products.
The ultrasensitive CRP test plays a vital role in healthcare by monitoring and assessing the risk of cardiovascular events. It allows for early detection of inflammation and vascular infections in individuals who may not yet show clinical symptoms.
🔗 For more information, please visit: Guidelines on health classification for ultrasensitive PCR parameter
Learn more about Brazil medical device regulations.
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