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Australia’s Therapeutic Goods Administration is conducting a postmarket review of face masks in response to concerns about the quality of some masks cleared for use during the coronavirus pandemic. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released new guidance for devicemakers on regulatory requirements for equivalent devices. 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
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Failure to document design inputs and outputs for its Lubricity dry mouth sprayer, as well as numerous other quality system lapses were uncovered during an inspection of YFS Pharma’s Buffalo, New York facility. Read More
A history of failing to submit medical device reports landed specification developer Circulatory Technology a third Form 483 for the firm’s Oyster Bay, New York, facility. Read More
Rick Bright, the ex-director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), said that he was removed from his post because he pushed back against the administration’s promotion of two anti-malaria drugs to treat COVID-19. 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
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
Congress last week allocated $25 billion to expand access to COVID-19 diagnostic tests as the FDA continues to pull out all the stops to get tests to the marketplace via Emergency Use Authorizations (EUAs) that exempt devicemakers from liability for product failures. Read More