CDRH posted seven new modules on the CDRH Learn web page at the end of September/beginning of October.
These new modules are:
Under The Basics
- How is CDRH Structured?
- Is My Product a Medical Device?
Under How to Study and Market Your Device
- Introduction to the Premarket Approval Application (PMA) Program
- Premarket Approval Application (PMA) Program: Postapproval Requirements
- How is My Medical Device Classified?
- Case Study: How is My Medical Device Classified?
Under Specialty Technical Topics
- Dental Devices Premarket Submissions
Most of the CDRH modules offer a recorded presentation, transcript, and printable slides. As I mentioned in a previous post, they are a good way to educate yourself about the regulatory process for medical devices. New modules are posted regularly – be sure to check back often.
Reach out to me if you want to know more or discuss your medical product development challenges.
Text Copyright © 2019 Katrina Rogers