Medtech Primer on the FDA Regulatory Landscape

"Medtech companies are subject to FDA regulation as medical device manufacturers if their products satisfy the 'device' definition in the Federal Food, Drug and Cosmetic Act (FDCA). As that definition explains, if a product is intended to diagnose, cure, mitigate, treat or prevent a disease, or is intended to affect the structure or any function of the body, it is regulated by FDA as either a drug or a device. If the product achieves its primary intended purpose through chemical or metabolic means, it is a drug; all other such medical products are devices under the FDCA."

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