What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19

FDA is exercising significant emergency authorities during the COVID‑19 pandemic.  Not all of industry is affected, but those who are manufacturing or distributing (or using) devices being used to fight the pandemic can benefit by understanding FDA’s emergency‑related policies and practices.  These are evolving every day, but we have gained enough experience, and there is now enough FDA guidance, that it seemed worthwhile to try to sketch out a roadmap, even if somewhat rudimentary.