FDA medical device registration and listing is a mandatory annual process. Medical device companies are required to register their facilities and list their specific products with FDA. It is a regulatory requirement for any company that manufactures or imports devices...
US FDA De Novo submission is a regulatory route for low to moderate-risk medical devices that lack a predicate device. It enables manufacturers to classify novel devices into Class I or Class II. This allows the device to be marketed in the US. Additionally, it can...
