Medical Device 2012 - FDA Medical Device Regulation for the Beginner

This 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device manufacturer’s and/or distributor’s regulatory responsibilities, requirements for labeling and user fees, fda inspections and enforcement.

Why Should You Attend:

This webinar is intended to provide the Beginner with an introduction to the U.S. Food and Drug Administration’s regulation of medical devices.

Areas Covered in the Seminar:
- Organizational Structure.
- Statutory and Regulatory Authority.
- Medical Device Classification System.
- Class I Medical Devices, 510(k) Premarket Notification and Premarket Approval.
- The Process for Bringing a Medical Device to Market in the U.S.
- The Components of a 510(k) Premarket Notification.
- A Manufacturer's Responsibilities.
- User Fees.
- Labeling and Promotion.
- An Introduction to the Quality System Regulation (21 CFR Part 820).
- The Import / Export of Medical Devices.
- Inspections.
- FDA Enforcement Activities.