Austin Marsh

Morrison & Foerster LLP

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Latest Posts › Food and Drug Administration (FDA)

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3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more

1/16/2018 / 3D Printing , Additive Manufacturing , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

Another Step Toward Reasonable Preemption Case Law

Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more

4/6/2017 / Abbott Laboratories , Birth Defects , Black Box Warnings , Food and Drug Administration (FDA) , Manufacturers , Preemption

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

4/1/2016 / Birth Defects , Failure To Warn , Food and Drug Administration (FDA) , Labeling , Pharmaceutical Industry , Preemption , Prescription Drugs , Summary Judgment

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more

3/2/2016 / Cybersecurity , Draft Guidance , Executive Orders , Food and Drug Administration (FDA) , Healthcare Facilities , Internet of Things , Manufacturers , Medical Devices , NIST , Popular

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

2/20/2015 / Failure To Warn , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Manufacturers , Pharmaceutical Industry , Preemption , Prescription Drugs

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