What is Diagnostic Cardiac Catheterization

Assignment Task 

Your employer has given you a new device or updated an existing device and asked you to get the FDA clearance. How do you determine a predicate device for your regulatory submission strategy Choose a new device or pick from the following: Ventilators, N95 masks, cardiac diagnostic catheters, etc. Use the 510(k) premarket notification medical device database to identify a predicate device. For example, if your product is an N95 mask, type N95 mask in the Device Name field. Choose one and make an argument for how it is substantially equivalent to your device. The Substantial Equivalency evaluation Flowchart must be included. The flowchart can be found in the below FDA guidance: The 510(k) program: Evaluating Substantial Equivalence in Premarket Notification 510(k).

This Management has been solved by our PHD Experts at My Uni Paper.