Thursday, 26 July 2018
5:30-8:30 pm CDT
26525 North Riverwoods Boulevard
First Floor, San Paulo Conference Room
Mettawa, IL 60045
+1 800 255 5162
FDA’s pre-market notification submission, also known as 510(k), is used widely to bring 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 Chicago Chapter invites you to join others from the local regulatory community to participate in interactive presentations from two subject matter experts. 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. One of the speakers will also discuss their experience serving on an AdvaMed Working Group that wrote the draft 510(k) guidance document for software changes, including how the group was able to influence the Agency to use a more risk-based approach. Following the presentation, attendees will break 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
- An explanation of the steps in the guidance document’s decision flow chart
Don’t miss this unique opportunity to take a deep dive into the 510(k) process with your colleagues. This event is coordinated by the RAPS Chicago chapter and is intended to encourage sharing your knowledge and participate in community development. Dinner will be provided and RAC holders may claim two RAC recertification credits.
Adrienne R. Lenz, RAC, senior medical device regulation expert, Hyman, Phelps & McNamara P.C.
Christine Shumard-Sauer, RAC, PhD, director, Protocol Link, Inc.
RAPS Members: $30