In a Law360 feature, Morgan Lewis partner Dennis Gucciardo and associate Jacob Harper highlighted some of the defining moments for the healthcare and life sciences industries in the year since the US government declared the COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration.
Dennis discussed the FDA notice earlier this year calling to permanently exempt 84 medical devices from 510(k) premarket notification. While permanent exemptions arguably make sense for some of the 84 devices, “it is unlikely” that the new administration’s FDA will fully follow through with the plan, he said.
Jake reflected on the response of the Centers for Medicare & Medicaid Services to the pandemic and said the agency “deserves a lot of credit” for how swiftly it revamped the telehealth landscape. “The interim final rules released in March and April 2020 were legendary,” he said in the feature.