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 delve into ten of the top reasons these hold letters are issues by the FDA, and how to avoid these questions and the premarket approval delays that come with such letters. We will explore the key reasons why the FDA may issue such holds, providing valuable insights for medical device manufacturers seeking regulatory clearance about how to avoid these costly delays caused by cybersecurity omissions and missteps.

Objectives

• Describe the cybersecurity activities that need to be performed during development
• Explain the cybersecurity artifacts that need to be included in the premarket submission
• Discuss the content that is needed in each artifact, and their specific formats