Cybersecurity, Medical Devices, New Guidance

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on 7/7/2025

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on 7/2/2025

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on 4/10/2025

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on 4/12/2024

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

FDA Publishes Implementation Policy Regarding Cybersecurity Requirements for Medical Device Premarket Submissions

Nelson Mullins Riley & Scarborough LLP on 4/17/2023

The U.S. Food and Drug Administration (FDA or the Agency) published guidance regarding cybersecurity requirements for certain device premarket submissions (the Guidance). The Guidance outlines the implementation of new...more

Cybersecurity in Medical Devices

BakerHostetler on 4/10/2023

The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more

Manufacturers of Instruments Routinely Used in In Vitro Diagnostics Should Carefully Consider FDA's Recent Cybersecurity Guidance

Wilson Sonsini Goodrich & Rosati on 12/6/2018

High throughput sequencers, including next generation, or NGS, sequencers; polymerase chain reaction, or PCR, machines; flow cytometers; and other instruments are routinely used in conducting in vitro diagnostic assays. Many...more

Cybersecurity › Medical Devices › New Guidance

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

New FDA Guidance on AI and Medical Products

FDA Publishes Implementation Policy Regarding Cybersecurity Requirements for Medical Device Premarket Submissions

Cybersecurity in Medical Devices

Manufacturers of Instruments Routinely Used in In Vitro Diagnostics Should Carefully Consider FDA's Recent Cybersecurity Guidance

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Red Notice Newsletter - October 2018

Security Vulnerabilities Identified In Wireless Syringe Infusion Pumps

Cybersecurity › Medical Devices › New Guidance

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