Tuesday, 13 March 2018
5:30–8:30 pm CDT
3832 Hillside Drive
Delafield, WI 53018
+1 262 646 7821
FDA’s premarket notification submission, or 510(k), is used widely to bring many medical devices to market in the United States. In a 510(k), sponsors submit documentation to demonstrate that the new or modified device is “substantially equivalent” to a predicate device in terms of intended use and technological characteristics. Submissions include information about the device, its labeling, how it compares to the predicate device and clinical and non-clinical test results.
The RAPS Wisconsin chapter invites you to join others from the local regulatory community to participate in this interactive activity. The program will begin with a detailed presentation on the fundamentals of the 510(k) process, with valuable information for both new and seasoned professionals. Following the presentation, attendees will break out into small discussion groups to further explore all topics related to the 510(k) process.
Discussion topics will include:
- When to use the 510(k) process
- The legal standards of the 510(k) process
- Substantial equivalence and predicate devices
- What to submit in a 510(k)
- How to manage the FDA interactive review process
Don’t miss this unique opportunity to take a deep dive into the 510(k) process with your colleagues. A light meal will be available for all participants and RAC holders may claim two RAC recertification credits.
Adrienne R. Lenz, RAC, senior medical device regulation expert, Hyman, Phelps & McNamara P.C.
Discussion Table Leaders:
Lisa Baumhardt, RAC, regulatory affairs compliance program manager, Merge Healthcare, an IBM Company
Tracey Fox, RAC, global regulatory affairs, IBM Watson Health
Robin F. Martin, MBA, RAC, co-founder and chief regulatory strategist, Kinetic Compliance Solutions, LLC
Margaret (Meg) Mucha, MS, RAC, FRAPS, senior leader, RA and QA, IBM Watson Health
Amy Yang, RAC, regulatory affairs manager, GE Healthcare
Prior to 3 March 2018
RAPS Members: $35
On or after 3 March 2018
RAPS Members: $45