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“We are convinced that the potential of the hybrid closed-loop systems will contribute to a more efficient and personalized approach of diabetes management," said Marcel Gmuender, global head of Roche Diabetes Care. Read More
When asking for a meeting, sponsors should include product information, such as a description of the combination product and constituent parts and proposed indications, the agency said. Read More
Of particular concern are regulatory considerations for devices made for particular patients, which are covered under the TGA’s current custom-made definition that exempts the products from regulatory requirements, such as inspections and third-party certifications. Read More
“Successful exploitation of these vulnerabilities together could result in the attacker being able to modify or fabricate data from the implanted cardiac device being uploaded to the CareLink Network and remotely execute code … which could allow control of a paired cardiac device,” DHS warned. Read More
The products enable physicians to position, reposition and cross the heart’s atrial septum without removing the guidewire, lowering the number of exchanges needed to conduct a variety of heart procedures. 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. Read More
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Read More
Australia’s Therapeutic Goods Administration (TGA) released new regulatory requirements for personalized medical devices that will go into effect on Feb. 25, 2021. 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
When undergoing an FDA inspection of a manufacturing plant, complying with agency requests and professional interactions with the investigators are the key, a panel of former FDA investigators advised during the 15th Annual FDA Inspection Summit hosted by FDAnews. Read More
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. 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