Enforcement Actions

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...