FDA regulation on decorative contact lenses


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:

  1. recognized in the official National Formulary, or the United States Pharmacopoeia, 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 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. The term "device" does not include software functions excluded pursuant to section 520(o).

Thanks in advance


Quite Involved in Discussions
Welcome to the Cove. I would encourage you to search the FDA Registration and Listing database on contact lens and see how they are classified for other spec developers, contract mfrs, and mfrs. This database will tell you a three character FDA classification code which will give you details on how regulated. If you know a particular competitor, you can search for them and the products they take responsibility for. I did a quick look and found that a case to hold a lens was regulated. Seems to me the pieces that go your eyes would be too. Hope this helps. Have fun.

Establishment Registration & Device Listing


Hi thank you for the inputs ;)
Yes I searched the FDA database before and the reason I was confused was that the product codes FDA used to regulate the contact lenses had intended uses like this:
A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
Product codes for contact lenses include LPM, LPL, MVN, HQD, MWL, NUU

So my question is: in a hypothetic case where I manufactured decorative contact lenses that were NOT intended to correct vision, by what regulations would FDA enforce discretion on my device? And why would my device fall within the scope of one of the product codes if it did not have the intended use described above?
*I don't actually work for a company that manufactures decorative contact lenses just curious


Quite Involved in Discussions
Understand. Suggestion. There are FDA resource emails where you can pose questions directly to them. I have found them helpful and responsive. You will get many very good opinions on this forum. However, there is no substitute for going to the authoritative source.
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