The 510(k) Submission: Requirements, Contents, and Options - Webinar By ComplianceOnline
August 28, 2012
Location
Online Event
2600 E. Bayshore Road
Palo Alto, California 94303
USA
Description
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.
Why Should You Attend:
This Medical device training 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.
Areas Covered in the Seminar:
- 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.
- What to do if you make a change to your device.
Organized by
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, California 94303
United States of America
More Information
Contact: Referral
Email: referral@complianceonline.com
Phone: +1-650-620-3915
Event's Website
