This question has been asked many times by persons that are unsure if their product is a medical device. In the past, some companies have played the ostrich game and believed as long as no one asked then everything was alright. Today, that mind-frame could be a major risk depending on the product and who is asking the questions. If one were to query the FDA database for their definition of a medical device the following definition would be found;
- An instrument, apparatus, implement, machine, contrivance, in vitro agent, or other similar or related article, including a component part, or accessory which is;
- Recognized in the National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of diseases in man or other animals, or
- 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 any of its primary intended purposes.
When FDA included the last bullet point in their definition it was meant as a catch-all to assist manufacturers in determining what is and is not a medical device. People often have the mind-set that if a product has no patient contact then it isn’t a device and that’s not necessarily so. If you make a product and question whether or not it’s a medical device give us a call here at Whip Mix and our regulatory department would be happy to help you determine that.
About the Author
John Waters is the Regulatory Compliance Officer at Whip Mix, overseeing the regulatory and quality assurance of products. He can be reached at firstname.lastname@example.org.