The Top 10 Reasons 510k Submissions Are Delayed for Cybersecurity

Session: 2009
Wed, May 21
12:15 PM-12:35 PM PT
TechTalk Stage - Expo Hall

The increasing connectivity of medical devices has brought about significant advancements in healthcare, but it has also introduced cybersecurity risks. The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and effectiveness of medical devices, and cybersecurity is now a primary focus of its premarket review process. This presentation will…