In our first webinar in this series, we will examine the requirements that the new FD&C Act's Section 5248 poses for new and upgraded medical devices.
The US Food and Drug Administration's 2022 passage of the Food, Drug, and Cosmetic (FD&C) Act included Section 524B. As a result the law now requires new or updated ‘connected medical devices to meet cybersecurity standards. Premarket submissions are at risk if these standards are not met.
How can device manufacturers ensure that their premarket submissions are accepted?
Leam more as Wind River will cover the practical impact of the new regulatory requirements, and outline technology strategies for compliance with the new standards.