We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Brazil’s National Health Surveillance Agency (ANVISA) is expediting approvals for medical devices and in vitro diagnostics related to the COVID-19 pandemic. Read More
The UK’s Medicines and healthcare Regulatory Agency (MHRA) is focused on building diagnostic capability for COVID-19 infections and is ramping up testing facilities across the UK via partnerships with universities, research institutes, diagnostics manufacturers and companies like Amazon and Boots. 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 agency is allowing laboratories to use tests they develop and validate before the FDA has issued an EUA for their test but will also allow states to authorize tests in some situations. 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
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
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