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“The diagnostic performance of the test is particularly good in samples with viral loads associated with high risk of viral transmission,” the researchers said. Read More
The United Kingdom will launch a new Medical Device Information System (MDIS) in January that aims to improve device monitoring and performance and link them to patient outcomes. Read More
Munich, Germany-based notified body TÜV SÜD has issued its first certificate for an in vitro medical device under the EU’s new In Vitro Medical Device Regulation (IVDR), marking the first IVDR certificate worldwide. Read More
Device manufacturers that have been denied a Certificate to Foreign Government (CFG) to export a product may file for a review of the decision, in a process laid out in a new FDA guidance issued Nov. 6. Read More
Singapore is introducing a unique device identification system and the country’s Health Sciences Agency plans to accept UDI barcodes from the U.S. and the European Union. Read More
The FDA attempted to provide clarity on an HHS announcement over the summer that it would no longer require premarket reviews of laboratory-developed tests (LDTs), including LDTs for COVID-19, but the attempt just muddied the water further, according to attorneys at Ropes & Gray. Read More
The FDA is having trouble meeting its performance goals under the Medical Device User Fee Amendments (MDUFA) IV program due to the COVID-19 pandemic and expects the delays to increase under the public health emergency is over. Read More
The International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual conference due to the COVID-19 pandemic. Read More
FDA investigators found various quality system lapses during inspections at five device facilities, including failure to fully investigate complaints and to submit medical device reports, among other deficiencies. Read More