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
Report as Spam


Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.

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


1000 N West Street | Suite 1200
United States