Introduction: The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND... Read more
Domestic and foreign manufacturers, distributors, or importers of medical devices in the USA must register their establishment with the FDA.
Your establishment license will be suspended if you fail to comply with regulations or present misleading statements in the application.
Every medical device manufacturing facility undergoes FDA inspection to ensure compliance with quality standards.