Receiving FDA (Food and Drug Administration) clearance or approval to distribute your medical devices in the U.S. is a rewarding process. But the real challenge to the medical device industry is the ability to maintain those clearances and approvals once received.
In this seminar, we will explore both the regulatory and quality system demands post-FDA clearance or approval. You will learn the importance of managing device changes and assessing the impact of the changes on your FDA approvals/clearance. We will explore real-life examples of device changes which would trigger a new approval/clearance as well as changes that can be managed internally through a letter to file. In addition, we will explore the FDA's international inspection process, which will include a comparison of the inspection process to the EU quality system audit, interviews and interactions with FDA officials, and the FDA's key focus on management with executive responsibility. In conclusion, we will explore FDA's regulatory enforcement options and how to response to FDA inspectional observations to prevent regulatory actions.
- Overview of the device change impact assessment on regulatory approvals/clearances
- Summary of the FDA international inspection process
- The do's and dont's of an FDA inspection and how to interact with FDA officials
- Comparison of the inspection/audit process in the US and Europe.
- FDA regulatory enforcement options and documents issued during inspections and after conclusion
- Overview of the process of responding to FDA-483, Inspectional Observations and how to prevent FDA regulatory action