Duration: 90 Minutes
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety/effectiveness, or when a series of lesser changes finally reach the “tipping point”.
Areas Covered in the Session :
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA’s current Guidance on 510(k) Device Modifications. This session will cover:
Who Should Attend: