510K - Understanding the Facts About the Pre-Market Notifications

All the companies planning to introduce a medical device in the US market need to submit an application to the FDA called a 510K. The 510K submission is needed for Class I devices, nearly all Class II devices and a very small number of Class III devices. As per the FDA Act, the FDA recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. ..»