Enforcement Actions

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...

Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due to the COVID-19 pandemic, there is an unprecedented number of EUA devices on the market, with many products being manufactured by...

The US Food and Drug Administration released a final rule to exempt additional product codes from the requirements of 510(k) submission. FDA believes that this exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs...

The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, but what exactly are they and how do you deal with them? To begin it’s important to note that an...