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FDA Solicits Comments Prior to Regulating 3D Printing of Medical Devices at the Point of Care

Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have...more

HHS Amends PREP Act Declaration to Facilitate Vaccine Rollout

On January 28, 2021, Norris Cochran, the acting secretary of the U.S. Department of Health and Human Services (HHS), amended the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical...more

What Product Liability Claims Can We Expect to See as a Result of COVID-19?

The COVID-19 pandemic created an environment where many companies are fighting unprecedented constraints to assist their customers and keep their businesses alive. As they tackle new demands daily — on their businesses and...more

FAQs: Are Component Part Manufacturers Entitled to Immunity Under the PREP Act, the CARES Act or the DPA?

Component part manufacturers of important lifesaving and life-protecting equipment have been essential players in the first line of defense against the COVID-19 pandemic. In the previously normal legal context, these...more

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