Renewing your USFDA registration involves several steps. Our USFDA team will help you through the process: 1. Prepare the required information: Our USFDA team ensures you have the necessary details about your facility and products. This includes: 2. Access the FDA’s FURLS System: The FDA uses the FDA Unified Registration and Listing System (FURLS) for […]

To obtain a USFDA FEI (Facility Establishment Identifier) number, a facility needs to register with the FDA. The process varies slightly depending on the type of facility (e.g., drug, medical device, food, biologics). Here are the general steps to acquire an FEI number through our USFDA experts. 1. Determine the Type of Registration Different types […]

The USFDA 510(k) process is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). Here are key points about the 510(k) […]