We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Numerous bugs were reported related to IT Synergistics’ LifeTec Elite version 1 and 2 blood establishment computer software but were not documented as complaints and weren’t investigated, according to a 483 the firm received following a March 5-6, and June 23 FDA inspection of its Flowood, Mississippi facility. Read More
Failure to submit a field report to the FDA, and failure to submit medical device reports were just two of the 13 quality lapses that dogged specification developer Craftmatic Industries found during an FDA inspection at its Pompano Beach, Florida facility. Read More