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The 510(k) Submission: Requirements, Contents, and Options - Webinar By GlobalComliancePanel
Dec 08,2010 - Dec 08,2010Online Training, Delaware, United States
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Highlights
Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
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.
Event Reminder
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Event Profile
- Speakers: Jeff Kasoff
- Attendees: 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 w
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