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The European Commission has released the first opinion by an expert panel assessing a product for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR), which will go into effect on May 26, 2022. Read More
Invacare has received a warning letter from the FDA for — among other failures — not fully investigating an incident in which a patient who was using one of its oxygen concentrators had to be taken to the hospital in an ambulance because the device wasn’t producing enough oxygen. Read More
Several major manufacturers of tests for the SARS-CoV-2 virus that causes COVID-19 are saying their products will detect infections caused by the new Omicron variant first identified in South Africa and now spreading rapidly around the world. Read More
Sixty-one senators of both parties have sent a letter urging the Centers for Medicare & Medicaid Services (CMS) to find a way for Medicare to pay for breakthrough medical devices, after the agency withdrew a previous proposal to do so. Read More
Production and process control failure is one of the most frequent citations in warning letters issued to devicemakers. According to FDA data, about 30 percent of warning letters citing Quality System Regulation (QSR) problems include production and process control issues; about 18 percent of the citations specifically mentioned 21 CFR §820.70(g), which covers equipment control. Read More
An electronic document management system (eDMS) should have internal and external safeguards to ensure that access to the computerized system and to the data is restricted to prevent unauthorized access. Read More
The FDA is planning to reclassify HIV viral load monitoring tests from high-risk class III devices requiring premarket agency approval into lower-risk class II devices requiring special controls and a premarket notification. Read More
Smiths Medical has received three complaints alleging deaths and seven complaints for serious injury due to malfunctions of its Medfusion pumps that it was slow to act on, the FDA said in a warning letter. Read More