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) […]