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FDA Issues Draft Guidance on Remanufacturing

Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices that are intended to be serviced over their […]

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Seven Snell & Wilmer product liability attorneys recognized as leaders in Product Liability Litigation – Defendants by The Best Lawyers in America 2020

Snell & Wilmer recently announced that 143 of the firm’s attorneys were selected by their peers for inclusion in The Best Lawyers in America©. Of those attorneys, seven partners were recognized in the practice area of Product Liability Litigation – Defendants. The 26th edition of The Best Lawyers in America includes attorneys in more than […]

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Snell & Wilmer Attorneys Publish Article on Medical Device Servicing and Remanufacturing

Denver partner Dan Wittenberg and associate Kelly Smith recently published an article, “Clarifying the Difference Between Medical Device Servicing and Remanufacturing,” in DRI’s For the Defense. The article explores the longstanding divide in the medical device industry between device manufacturers and the third-party entities that service the devices. Wittenberg and Smith explain how the FDA […]

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FDA Makes Gene Therapy Available for First Time in USA

Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the FDA. The product, Kymriah (tisagenlecleucel), is for certain pediatric and young adult patients with a form of acute […]

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Senate Confirms New FDA Commissioner

Dr. Scott Gottlieb was confirmed today as the new FDA Commissioner.  Dr. Gottlieb has promised to put public health first and not do anything “that shakes the public’s confidence in the agency.” He is a former hospitalist who served in the FDA during the George W. Bush administration, lastly as its deputy commissioner for medical and […]

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One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

By Daniel S. Wittenberg, Co-Chair, Medical Device and Pharmaceutical Industry Group On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs” specifically states that in an effort to “manage the costs associated with the […]

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Summary of FDA Draft Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

By Daniel S. Wittenberg and Tim Scalo[1] On June 16, 2016, the Food and Drug Administration (FDA) released a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions[2].  The non-binding draft guidance provides clarity to FDA staff and the medical device industry by setting out the benefit […]

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FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar  –  Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer Inc., for treatment of rheumatoid arthritis, inflammatory bowel diseases and other conditions.  Inflectra is a biosimilar to Remicade which has been […]

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Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court has agreed to hear an appeal of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the doctrine was inconsistent with Arizona’s system of pure comparative fault. Under the widely adopted learned intermediary doctrine, a drug manufacturer, for example, is […]

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Former Partner

FDA Issues Unprecedented Alert Over Medical Device Cyber Security Risk

A fictional cyber-terrorist weaponizing a medical device by hacking into it has become a familiar plot premise in recent Hollywood dramas. Unfortunately, the risk of harm from medical device hacking has now become an actionable, real-world concern. In an unprecedented move, on July 31 the U.S. Food & Drug Administration issued an Alert to health care facilities to discontinue […]

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