Conference Workshop & Welcome Reception Agenda
TUESDAY, MAY 5, 2020
8:30 AM - 4:00 PM
Conference Workshop: What You Always Wanted to Know About 510(k), but Were Afraid to Ask…Until Now
The vast majority of medical devices on the market in the United States have successfully navigated the FDA 510(k) process. This strong 510(k) review process is critical to FDA’s mission of protecting and advancing public health. Expert facilitators will engage you in discussion during this hands-on, practical workshop, to provide you with firm insight on when the 510(k) process is right for your company, how to effectively support your product development with data, when to engage FDA in your 510(k) strategy, and when to notify FDA of changes to your product.
12:00 pm - 4:00 pm
Office Hours with FDA
Erica M. Katherine, Associate Ombudsman, FDA-ORA, invites you to reserve a session to discuss your specific questions one-on-one, or with your team, so she can focus on you, your company, and your concerns.
5:00 pM - 7:00 PM
Please join the MedCon Strategic Committee at the Hilton Cincinnati Netherland Plaza hotel for an evening welcome reception, to reconnect with colleagues and make new connections. Light hors d’oeuvres and beverages will be served.