As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve public health each day is more important than ever. The American Public Health Association celebrates the week of April 5th- April...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA...
Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement of the FDA Reauthorization Act (FDARA) of 2017. The FDARA was signed into law on August 18, 2017, and amends the Federal Food, Drug, and...
FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand the implications of the pandemic on their pre-market submissions made to the FDA. As per this guidance, FDA says the...
The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever done. Relaxed regulations allow quick access to critical medical devices necessary to fight the pandemic, but what will happen to the medical...