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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. The Government of Canada’s number one priority is to protect the health of Canadians.

FDA 52
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The FDA and Feasible Alternative Designs

Drug & Device Law

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59