Tag Archives: medical devices

FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the…

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FDA Issues Guidance for Wireless Technology in Medical Devices

The Federal Drug Administration issued a guidance for Radio Frequency Wireless Technology in Medical Devices.  The guidance does not establish legally enforceable responsibilities but describes the FDA’s current thinking on this topic. The guidance document addresses a myriad of considerations that may affect the safe and effective use of medical devices that incorporate wireless technology, including the selection of wireless technology, quality of wireless service, coexistence with other wireless technologies, security and electromagnetic compatibility.  Citing 21 CFR 820.30, which regulates design controls, the FDA…

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More Class III Medical Device Decisions

Two more preemption cases involving Class III medical devices were recently decided.  One was a 12(b)(6) motion to dismiss, and the other was decided in the context of a motion to amend a complaint to add a failure to warn and a breach of warranty claim.  The standard of review for the two motions is the same. The first case we discuss (Gavin v Medtronic) involved a variety of legal theories based on alleged off label promotion by the manufacturer.  The court rejected…

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