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The cost of the hand-held auto-injector form of the drug, Evzio, has increased from $690 for a two-pack in 2014 to $4,000, according to Michigan senators Debbie Stabenow and Gary Peters. Read More
The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai. Read More
The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions. Read More
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but it is making adjustments to help manufacturers comply. Read More
The updated fees range from $147,012 for registering a new Class IV device, $107,998 for a Class II/III device and $86,114 for a reprocessed single-use Class IV device. Read More