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FDA Regulation and Approval of Medical Devices: 1976-2020

FDA Regulation and Approval of Medical Devices: 1976-2020
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Form F-1/A Inspira Technologies

Form F-1/A Inspira Technologies
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Massachusetts Supreme Judicial Court Dismisses Medical Device Suit | White and Williams LLP


Last week, in
Dunn v. Genzyme,[1] the Massachusetts Supreme Judicial Court (SJC) provided clarification as to the pleading standard that applies to state product liability claims against medical device manufacturers. Under
Riegel v. Medtronic,[2] such claims survive federal preemption under the Medical Device Amendments (MDA) of the Food, Drug, and Cosmetic Act, so long as the state claims parallel (and do not supplement or conflict with) federal law.
But courts have reached conflicting results as to whether the alleged “parallel” violation of federal law must be pleaded with specificity. Some courts require detailed pleading where they will dismiss a complaint unless the plaintiff “allege[s] that the defendant violated a particular federal specification relating to the device at issue.”[3] Other courts are more lenient, where they do not require that plaintiffs “specify the precise defect or specific federal regulatory requirements that were allegedly viol ....

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New York Medical and Life Sciences: Year in Review 2020 | Harris Beach PLLC


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From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices and other FDA regulated products, it is often helpful to step back and review holdings that have affected the industry and may shape the year ahead.
In the
New York Medical and Life Sciences: Year in Review 2020, we review, analyze and share potential implications for future life science cases, based on several key judicial holdings in New York in 2020 pertaining to: ....

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