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Health Canada Proposes Changes to Priority Review Requests for Medical Device

Health Canada intends to modify its policy for medical device manufacturers to request priority reviews by nixing its requirement on a separate submission and adding a new required criterion for eligibility.


FDA launches pilot to shorten some 510(k) approval times

The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets.


Which country should I go to for my clinical trial?

Which country should I go to for my clinical trial?