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…
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…
The US FDA Establishment Identifier (FEI) number The FDA Establishment Identifier (FEI) number is a unique identifier assigned by the U.S. Food and Drug Administration (FDA) to regulated establishments. This…