Not all devices are regulated equally, but oftentimes the line isn’t very clear for medical devices. Medical devices can range from very simple to incredibly complex. They could be as small as a tongue depressor, to as incredible as a programmable pacemaker. In vitro diagnostic tests are also considered medical devices. Because the definition of a medical device is so loosely applied, many manufacturers are unsure whether their product sp[ecifcally meets the requirements to be considered one. Here are the steps you can take to recognize whether your product needs to be regulated by the FDA as a medical device.

Determine Whether your Product Fit the Definition by the FDA

Any medical device that fits a classification per Section 201(h) of the Food, Drug & Cosmetic Act will be regulated by the FDA. This will help you also identify whether there is a current classification for your product. The FDA’s definition of a regulated device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–

  • recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
  • (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • (3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

If a device fits the FDA’s definition, then it will be subject to regulation.

Leave a Reply