Tag Archives: device

Practical Considerations for Device Industry Policyholders Experiencing Puerto Rico Hurricane Losses

Last week, FDA released a statement about the challenges facing the medical device manufacturing industry in Puerto Rico in the wake of Hurricanes Irma and Maria. FDA is concerned that the damage to the island will lead to shortages of important medical products. The statement highlights that device manufacturers both inside and outside Puerto Rico … Continue Reading

Court Rejects FDA’s Interpretation of the Statute’s Device Definition as “Erroneous and Unreasonable”

The United States District Court for the District of Columbia, in Prevor v. FDA (Prevor II), rejects for the second time FDA’s “erroneous and unreasonable interpretation” of the definition of “device” under the Federal Food, Drug and Cosmetic Act (FDCA) (op. at 21).  The court has remanded the case to FDA to use a lawful standard … Continue Reading
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