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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
The International Medical Device Regulators Forum released new consultation documents on personalized medical devices and on optimizing standards for regulatory use following its March meeting in Shanghai. Read More
The FDA announced draft guidance introducing an optional submission process for determining the risks or non-risks of using an investigational in vitro diagnostic in a clinical trial involving an oncology investigational drug. Read More
The FDA issued two new guidances on development of in vitro diagnostics that use next generation sequencing (NGS) technology to create individualized, genetic-based medical plans tailored to specific patients. Read More