Canada’s Minister of Health issued an interim order on the conduct of clinical trials for medical devices and drugs intended to treat COVID-19. The order, published in the June 6, 2020, Canada Gazette, applies to the import and sale of a device, other than class I devices, or a drug, other than those described in Schedule C, that will be tested in a COVID-19 clinical trial. Products in a trial with a valid COVID-19 authorization will be exempt from Canada’s Medical Devices Regulations and certain drug regulations, according to the order. Besides explaining how to apply for a COVID-19 drug or device authorization, the interim order addresses a variety of clinical trial issues, including the need for approval from a research ethics board and labeling
Intersect ENT Inc., of Menlo Park, Calif., said the Centers for Medicare and Medicaid Services has approved a new C code and pass-through payment status for the company’s Sinuva sinus implant for recurrent nasal polyp. The implant treats the affected tissue with 10 micrograms of mometasone furoate, and the company said 70% of those enrolled in commercial health plans already have access to the device. Coverage in fee-for-service Medicare means another 40 million Americans will have access to the Sinuva, the company said.