I have a general question: US FDA has issued several publications stating that decorative lenses without the function of correcting vision are also regulated as medical devices.
But by what regulations does FDA regulate decorative contact lenses?
For example, now EU MDR has clauses that clearly state the decorative contact lenses fall under the scope of MDR.
Are decorative contact lenses considered to affect the structure or function of the body? Or how will they fall into the definition of medical device?
The definition of a medical device is as follows according to FDA website:
Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
Thanks in advance
But by what regulations does FDA regulate decorative contact lenses?
For example, now EU MDR has clauses that clearly state the decorative contact lenses fall under the scope of MDR.
Are decorative contact lenses considered to affect the structure or function of the body? Or how will they fall into the definition of medical device?
The definition of a medical device is as follows according to FDA website:
Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- 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 its primary intended purposes through chemical action within or on the body of man or other animals and
Thanks in advance