You’ve invented a great new product but you aren’t sure if it is subject to regulation as a medical device? Medical devices range from simple tongue depressors to complex laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers.
So what about your product? Working with your attorney, you’ll evaluate the below criteria to determine if your product meets the definition of a medical device (“device” herein). If it does meet the definition, there are FDA requirements that apply.
If a product is labeled, promoted or used in a manner that meets the following definition from the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls.
So what is a medical device?
A medical 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,
• 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
• 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 (21 U.S.C. 321(h)). The term “device” does not include software functions excluded pursuant to section 520(o).
The gist: The above definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug.
If you have any questions, the Law Office of Robert P. Mino, PA is here to help. Contact us today!