The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
Timely compliance will ensure that your products will not be considered misbranded.
The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.
Selling expired devices? Oh, no.
Regardless, let’s look at stupidity in its highest form.
What’s up with the trend in Class I initiated recalls?