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...
US FDA 510(k) Dossier Preparation: Everything You Need to Know
510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...
5 Pro tips for Hassle-Free US FDA 510(k) Submission
Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The FDA 510(k) is a premarket submission process used to determine whether the medical device is safe and effective. Owing to incorrect application, thousands of...