This is an interesting question. Let's try to unravel the meaning of "medical purpose"
The FDA uses the term "medical purpose" in a variety of guidance documents. Let us examine two excerpted quotes from FDA documents and one from a sister agency CMS (Centers for Medicare and Medicaid Services).
1. "As described in 21 CFR 878.9, exemption of class I devices does not apply where: 1) the device is intended for a different use, e.g., a different medical purpose; or 2) the device operates using a different fundamental scientific technology."
Here, as you can see, the term "medical purpose" is used as an example of a "medical
2. "Accordingly, a class II device listed in this document is not exempt if such device: (1) has an intended use that is different from the intended use of a legally marketed device in that generic type; e.g., the device is intended for a different medical purpose, or the device is intended for lay use instead of use by health care professionals; or (2) operates using a different fundamental scientific technology than that used by a legally marketed device in that generic
Here, the term "medical purpose" means its "intended
3. "DME is medical equipment DME is medical equipment which is which is primarily and customarily used for primarily and customarily used for medical purposes and is not generally medical purposes and is not generally useful in the absence of illness or useful in the absence of illness or
"This quote is referring to Durable Medical Equipment, such as wheelchairs. It adds the useful explanation that such a device would not generally be useful "in the absence of illness or injury". This brings us to the definition of "medical
A medical device is a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C)
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which
recognized in the official 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 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 any of it's 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."
I would conclude that a
"medical purpose" means that the intended use is in accordance with the
definition of medical devices.