The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food, including animal food, and electronic products that emit radiation. Canada’s equivalent is Health Canada (HC) and focuses on helping Canadians maintain and improve their health.
During Dickinson Wright’s 2021 Health Law Virtual Summit, Billee Lightvoet Ward (Of Counsel, Grand Rapids) and Wendy Hulton (Partner, Toronto) discussed the demand that the COVID-19 pandemic created for specific medical equipment and products that many businesses pivoted to supply. For example, hockey equipment suppliers made shields in Canada while alcohol producers began supplying hand sanitizers and sterilizing wipes.
The FDA and HC worked quickly to accommodate these businesses entering the scene, tweaking regulations to allow Emergency Use Authorizations (EUA) to keep up with the demand for certain regulated items, including PPEs, masks, and sanitizers. Of note, only in deficit do the agency’s “new rules” apply – once there’s a sufficient supply of items, companies must follow the traditional route for obtaining approvals.
Most US companies naturally want to expand into the Canadian markets and other jurisdictions and vice versa. What does it look like to enter the market at this stage, including cross-border practices?
Three steps to successfully bring your commercial products to market:
Identify which party takes on which role – whether you are the fabricator, labeler, manufacturer, or distributor.
The US has three classes for medical devices, and the risk goes up with each class. Classification dictates your next steps. In Canada, class one wouldn’t typically be licensed, but classes two and three would.
Things are calming down and slowly getting back to normal, which means more investigations and auditing. From the FDA’s standpoint, COVID-related products, such as vaccines and at-home testing, will continue to be a priority, along with privacy and cybersecurity and the impact on the delivery of medical services.