FDA's New Cybersecurity Requirements: Are You Prepared as a Medical Device Manufacturer?

## Executive Summary This article outlines FDA premarket cybersecurity expectations for medical device companies ahead of an October 1, 2023 deadline, advising organizations to implement vulnerability monitoring and remediation processes, establish a Vulnerability Disclosure Program (VDP), ensure timely patching and communications for critical issues, and produce and maintain a Software Bill of Materials (SBOM) to reduce patient risk and avoid regulatory refusal of device approvals.