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The FDA issued five new warning letters last month related to misbranded and adulterated COVID-19 tests, as the agency continues to urgently target manufacturers and suppliers of unapproved COVID-19 products. Read More
The European Commission is calling on EU standardization groups to revise more than 200 existing harmonized standards and to draft 27 new standards over the next three years in support of the EU’s Medical Device Regulation and In Vitro Device Regulation. Read More
The FDA has announced that it will conclude its Quality in 510(k) Review Program pilot after May 30 and will no longer accept submissions after that date, directing companies to consider using its electronic Submission Template and Resource (eSTAR) pilot program instead. Read More
The FDA has reversed a Trump Administration policy that was set to exempt 83 class II devices and one unclassified device from premarket notification requirements. Read More
Australia’s Therapeutic Goods Administration (TGA) has outlined its expectations for developers of in vitro diagnostic (IVD) self-tests for infectious diseases like influenza, hepatitis B and hepatitis C, chlamydia, gonorrhea and syphilis. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) resumed in-person inspections on March 29 but it is adopting a hybrid approach that allows for both remote and on-site elements. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that paclitaxel drug-coated balloons or drug-eluting stents should not be used in the routine treatment of patients with widening of the arteries, as the mortality risk generally outweighs the benefits. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, a combination drug/device manufacturing facility in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
The FDA issued a warning letter to Tarmac Products, a Miami Gardens, Florida manufacturer of surgical wound dressings for issues with its medical device quality system. Read More
The EU’s Medical Device Coordination Group (MDCG) has clarified minimum performance requirements for devices intended to detect antibodies against the SARS-CoV-2 virus in a new guidance. Read More