Our Regulatory Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

What is a 510(k)? North America

What is a 510(k)?

Any manufacturer who wants to legally market their medical device in the US intended for human use has to get FDA approval. Any class I, II, or III devices, which is not exempt and does not require premarket approval must fulfill the requirements of a 510(k) of the...

Read More