MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 24, 2024


1:15 pm


1:30 pm

FDA Voluntary Improvement Program: Fostering Medical Device Improvement

Digital Health Track

In 2023, The FDA announced a final guidance entitled “Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program.” The program, facilitated through the Medical Device Innovation Consortium (MDIC), is intended to guide improvements to enhance the quality of devices. This session will provide an overview of FDA’s participation and engagement with the Voluntary Improvement Program.


Kim Shoemaker, Senior Director, Global Regulatory Affairs, Johnson & Johnson MedTech


Erin Keith, Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA