Cross-Border Regulating: US and Canada Complete Their First Joint Device Review

article image

A Medtronic device underwent a “joint” FDA-Health Canada premarket review last year as the first phase of a pilot project that the agencies hope will serve as a platform for a broader global Medical Device Single Review Program.

A global single premarket review for medical devices seemed like a pie-in-the-sky goal a few years ago, but some very tangible steps toward that objective have been taken of late, principally by Health Canada and US FDA. Most notably, the two agencies conducted their first “parallel/joint review” of a device last year and are now looking for more products to take on a premarket harmonization test drive.


This article is restricted to subscribers only.

Sign in to continue reading.


We're here to help! Please contact us at: