8 Step Guide to FDA 510(k) Pathway for Unclassified Devices
The primary focus of FDA 510(k) pathway is Class I and Class II medical devices. However, medical devices that lack formal classification may still be eligible for 510(k) clearance. Unclassified devices can still follow the FDA 510(k) pathway, if a legally marketed...
US FDA 510(k) Third Party Review: Everything You Need to Know
The FDA 510(k) Third Party Review Program is a voluntary alternative review pathway. It allows accredited third-party organizations to review certain low- to moderate-risk medical device submissions instead of the FDA itself. The Third Party Review process helps...
US FDA Medical Device Classification System: Your Guide
The FDA classifies medical devices into three categories based on associated risk level. Each device class requires a different level of regulatory control. These guidelines are in place to ensure the safety and effectiveness of the device. Hence, manufacturers...