Wednesday, 13 February 2019
11:30 am - 5:00 pm EST
Alcon Laboratories, Inc.
11460 Johns Creek Parkway
Commons Building #3
Duluth, GA 30097
+1 678 415 3937
The RAPS Atlanta chapter invites you to come engage with others in your local regulatory community for a hands-on workshop to learn about the 510(k) submission process.
Most medical devices in the US today are marketed under the premarket notification (510(k) authorities of the Federal Food, Drug and Cosmetic Act. In order to market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different. The purpose of this workshop is to provide participants with an understanding of:
- regulatory fundamentals
- practical guidance on how to develop, prepare and submit a 510(k) to FDA
- 510(k) submission types
- changes being discussed by FDA to this submission process
- how to engage with FDA
Scheduled presentations include:
- Regulatory Fundamentals - Device Classification, Introduction to 510(k) and Types of 510(k)s
- Practical Guidance on How to Develop, Prepare and Submit a 510(k), Including Product Codes and Predicate Devices
- Practical Guidance on 510(k) Test Requirements, Software and eCopy
- Changes in the Submission Process and Engaging with FDA
The workshop will also include case studies where attendees break out into groups based on experience to collectively classify a device, determine a predicate and the appropriate submission type and then create a high level 510(k) outline and strategy.
This workshop, hosted by Alcon Laboratories, Inc., is brought to you by the RAPS Atlanta Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Don’t miss this unique, hands-on opportunity to learn about the 510(k) submission process. Lunch will be provided to all attendees and RAC holders may claim five RAC recertification credits.
Melissa O'Connor, MS, RAC, CTBS, vice president of quality assurance and regulatory affairs, StimLabs, LLC
Grace Powers, MS, MBA, RAC, founder and principal consultant, Powers Regulatory Consulting
Beatrice Wan, MBA, RAC, senior regulatory specialist, Becton Dickinson
RAPS Members: $69