From Concept to Market: FDA Approval Process for Medical Devices

In this article for QT9 QMS, Menaka Manokaran, Associate Director of Regulatory Affairs at Lumanity, reviews the FDA approval process for medical devices.

The article examines Special 510(k) and Abbreviated 510(k) submissions, as well as premarket approval, the most stringent type of device marketing application required by the FDA.

Read the article on the QT9 QMS site.