by Naveen kumar | Jun 15, 2024
Navigating the Premarket Notification (510(k)) Process Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical...
by Naveen kumar | Jun 2, 2024
In this article, we are going to see the outline of the combination products and their regulations. so what are combination products – In the US combination products are defined in 21 CFR 3.2(e). and in the EU combination terms are not used instead they use...
