EMERGO SUMMARY OF KEY POINTS:
- Health Canada’s Pre-Clinical Meeting program to provide feedback and recommendations to medical device manufacturers before they undertake clinical investigations.
- Pre-Clinical Meeting program pilot to run from November 2018 to March 2019.
- Formal Pre-Clinical Meeting guidance to be published following program pilot.
Canadian medical device regulator Health Canada is preparing a pilot for a new program allowing manufacturers to request meetings with the agency for feedback on proposed clinical investigation protocols and related issues.
According to a new Health Canada notice, the pilot for its Pre-Clinical Meeting program will begin in November 2018 and run until March 2019. The program will establish a formal process whereby medical device companies may request meetings to obtain advice and recommendations from the regulator about their investigational testing protocol designs before submitting Investigational Testing Authorization (ITA) applications for approval.
Following the Pre-Clinical Meeting program’s pilot phase, Health Canada plans to publish new guidance to formalize the process.
Pre-Clinical Meeting pilot eligibility
The Pre-Clinical Meeting program pilot is targeted at medical device manufacturers planning on submitting ITA applications for Class III or Class IV devices, as well as for Class II devices qualifying as novel or disruptive technologies. Eligible companies must also have selected Canadian investigation sites as well as detailed clinical investigation protocols…