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The Medical Device Innovation Consortium (MDIC) is asking for feedback on its new draft framework for using real-world evidence (RWE) in the development and clearance of in-vitro diagnostics (IVDs). Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More
The EU’s Medical Device Coordination Group released a guidance for devicemakers on transitional provisions for Class I devices under the Medical Device Regulation (MDR). Read More
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Read More
The FDA cited six U.S. devicemakers for a variety to quality failures including failing to submit medical device reports or to maintain a device master record. Read More
To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Read More
Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Read More
The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Read More
The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Read More
The European Commission has adopted a proposal to delay implementation of the EU Medical Device Regulation (MDR) for a year due to the COVID-19 pandemic. Read More
The International Medical Device Regulators Forum (IMDRF) released final guidance on harmonized regulations for adverse event reporting, cybersecurity, and personalized medical devices. Read More