RegDesk Regulatory Roundup

Jun 2, 2016

Reminder: UDI Implementation Due Date Approaching

The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...

Aug 29, 2014

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...