The U.S. Food and Drug Administration (FDA) has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System,
... Read more
The FDA has opened a request for feedback on generative AI medical devices, inviting responses from manufacturers, clinicians, researchers, and
... Read more
The U.S. Food and Drug Administration (FDA) has issued a proposal under the FDA Reauthorization Act of 2017 (FDARA) to
... Read more
The U.S. Food and Drug Administration (FDA) has published the medical device user fee rates for fiscal year 2027, setting
... Read more
Health Canada has opened a public consultation on proposed changes to the List of Recognized Standards for medical devices. The
... Read more
Health Canada has finalized the second phase of amendments to modernize medical device establishment licensing in Canada. The amended Medical Devices Regulations
... Read more
Health Canada has strengthened its drug and medical device shortage framework. On June 17, 2026, the department published amendments to
... Read more
The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k) premarket notification requirements, formally
... Read more
The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the
... Read more
The U.S. Food and Drug Administration published a notice in the Federal Register on May 1, 2026, announcing its intent
... Read more
Missing your MDEL renewal deadline puts your entire Canadian market access at risk. Under the Medical Devices Regulations (SOR/98-282), all Medical Device
... Read more
Artificial intelligence (AI) is reshaping the medical device industry, making diagnostics, treatment planning, and patient monitoring more efficient than ever.
... Read more
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more
