Navigating US FDA 510(k) Database: A Step-by-step Guide
The US FDA 510(k) database is a centralized repository of all US FDA 510(k) submissions, clearances, and approvals. Hence, medical device manufacturers are required to refer to the US FDA 510(k) database preparing for FDA 510(k) clearance. Information from the...
How to Identify a Predicate Device? A Detailed Guide
Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...