FDA Approval Process and Challenges in Embedded Cybersecurity for Medical Devices

This chapter focuses on the process of obtaining FDA approval for medical devices with embedded software and the challenges in implementing cybersecurity measures in these devices. It discusses the recent draft guidance issued by the FDA on cybersecurity for medical devices, emphasizing the need for prescriptive measures. The chapter also highlights the variation in cybersecurity practices among different hospitals and the importance of investing in proper cybersecurity measures to prevent ransomware attacks.