US FDA Medical Device Registration and Listing: Complete Guide
FDA medical device registration and listing is a mandatory annual process. Medical device companies are required to register their facilities and list their specific products with FDA. It is a regulatory requirement for any company that manufactures or imports devices...
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...