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- COVID-19: Regulatory Considerations for Medical Device Companies
COVID-19: Regulatory Considerations for Medical Device Companies
March 29, 2020, Covington Alert
Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other recently announced FDA policies as well as considerations in the EU. We also explain how the public health emergency impacts ongoing premarket and postmarket activities of FDA and device manufacturers.
HHS Publishes Notice Exempting Devices from Premarket Review in Final Days of Trump Administration
February 2, 2021, Covington Alert
On January 15, the final Friday of the Trump administration, the Department of Health and Human Services (“HHS”) published in the Federal Register a notice permanently exempting or proposing to exempt 101 medical devices that previously required a premarket clearance under section 510(k) of the Food, Drug & Cosmetic Act (“FDCA”). Under the notice, seven class I ...
May 18, 2020, Covington Alert
Businesses are developing plans for reopening workplaces. As they do, many employers are considering ways to determine which employees can safely return to the workplace, and what protective equipment should be provided to employees once they return. In both the United States and European Union, many of the products used in these strategies are regulated as ...
December 20, 2017, Covington Alert
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...