Wait, Wait…Don’t Sell Me! FDA and Other Pre-Market Considerations for Commercial Products

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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?

  • Consider what it looks like to commercialize and distribute your products.
  • Look at the different regulatory requirements in the different countries.
  • Understand how the FDA and HC differ in the way they approach the regulation of these products, as well as the way some medical devices are categorized.

Three steps to successfully bring your commercial products to market:

  1. Know Your Product.
  • The physical characteristics.
  • The intended use of the product – labeling and marketing as well as claims made in relation to the product.
  • How it fits within the FDA (HC) categories.
  • There are many different definitions, and you can have a combination product (i.e., a product classified as both a device and drug).
  1. Know your role and figure out what rules apply.

Identify which party takes on which role – whether you are the fabricator, labeler, manufacturer, or distributor.

  1. Classify your product – and take steps to comply.

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.

  • Class I General Controls. Examples include tongue depressors, examinations gloves, bandages, and hand-held surgical instruments.
  • Class II General Controls and Special Controls. An example would be powered wheelchairs.
  • Class III General Controls and Special Controls. Examples include implantable pacemakers and breast implants.

Looking Ahead.

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.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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