Before we get to the primary topic, you should know that the United States FDA Registration Renewal period closed on December 31, 2020. If your renewal was not processed by the deadline, you are required to go through the FDA re-registration process. Today, we’d like to briefly talk about the number of FDA Unique Device...Read More

A labeler is identified by the FDA as any entity that causes a label to be attached to a product to commercially sell the device without any subsequent substitution or alteration of the label.Also…An individual who causes the label of a product to be replaced or altered to sell the device commercially without any resultant...Read More