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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
Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has released new guidance on antigen testing. 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
Australia’s Therapeutic Goods Administration (TGA) said that, in light of delays due to the COVID-19 pandemic and limitations on the number of notified bodies designated under the European Medical Devices Regulation, devicemakers could see their conformance assessment documents lapse for their listed devices on Australia’s Register of Therapeutic Goods. Read More
“We recommended that CMS adapt and streamline existing processes to allow for rapid reviews of breakthrough devices, while still fully considering the evidence needed to ensure their safety and effectiveness,” AHIP said. Read More