The 510(k) Submission: Requirements, Contents, and Options - Webinar By GlobalCompliancePanel
Venue: Online Training Webinar
Location: Wilmington, Delaware, United States
Event Date/Time: Dec 08, 2010 | End Date/Time: Dec 08, 2010 |
Description
Areas Covered in the Session:
* When to submit a 510(k) for a new or modified product
* Types of 510(k) submissions and when to use each
* What is the submission process
* What is contained in a 510(k) submission package
* How to know whether clinical data is required
* How is the submission package assembled
* User fees and 510(k) submissions
* How to interact with the FDA and the reviewer
Who Will Benefit: This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:
* Executive Management
* Regulatory Management
* Professionals involved with premarket notification to the FDA
* R&D personnel involved in approving the design of medical devices
* Sales personnel involved in approving the marketing of medical devices