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...
A Guide to US FDA De Novo Submission Process and Timeline
US FDA De Novo submission is a regulatory route for low to moderate-risk medical devices that lack a predicate device. It enables manufacturers to classify novel devices into Class I or Class II. This allows the device to be marketed in the US. Additionally, it can...
US FDA IVD Classification System: A Comprehensive Guide
In vitro diagnostics (IVDs) have a vital role in improving patient outcome and public health surveillance. IVDs are used to detect diseases, monitor health conditions, guide treatment decisions, detect diseases early on, and support precision medicine. Hence, IVDs...
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...