News & Analysis as of May 28, 2025

Food and Drug Administration (FDA)

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

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

FDA Issues Guidance on Mobile Medical Devices

Ballard Spahr LLP on 4/1/2015

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

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