Regulatory Open Forum

According to FDA, there is no such thing as a "cosmetic claim" for a device.

A cosmetic product has to meet the following criteria:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance"

In other words, you can make "cosmetic claims" for a cream, ointment, powder, liquid etc, but not a device.

According to FDA, the definition of a device is:

A medical device is defined within the Food Drug & Cosmetic Act as "...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 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."

Years ago I had a non-US client who had had a run-in with FDA over a plastic mask with slot for magnets which were supposed to be placed at the same locations as acupuncture sites. The manufacturer claim was that the mask would cause a lifting effect - same as many cosmetics. He firmly believed that the cosmetic intent freed him from having to get the device cleared, but that little clause in the device definition about affecting the structure in the device definition put it firmly in the jurisdiction of CDRH. FDA insisted in seeing a cleared 510(k) before allowing it to be marketed. He was willing initially, but dropped it after seeing the cost of testing and clearance.

There  are some ugly warning letters on the FDA website and I warn my clients who I think might be trying to take the low road that once a warning letter is on the internet (I call it the "Hall of Shame"), a google search of the name of the CEO will forever after turn up that letter. That is usually enough to deter them from marketing a product that isn't properly cleared.

Good luck!

According to FDA, there is no such thing as a "cosmetic claim" for a device.

A cosmetic product has to meet the following criteria:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance"

In other words, you can make "cosmetic claims" for a cream, ointment, powder, liquid etc, but not a device.

According to FDA, the definition of a device is:

A medical device is defined within the Food Drug & Cosmetic Act as "...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 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."

Years ago I had a non-US client who had had a run-in with FDA over a plastic mask with slot for magnets which were supposed to be placed at the same locations as acupuncture sites. The manufacturer claim was that the mask would cause a lifting effect - same as many cosmetics. He firmly believed that the cosmetic intent freed him from having to get the device cleared, but that little clause in the device definition about affecting the structure in the device definition put it firmly in the jurisdiction of CDRH. FDA insisted in seeing a cleared 510(k) before allowing it to be marketed. He was willing initially, but dropped it after seeing the cost of testing and clearance.

There  are some ugly warning letters on the FDA website and I warn my clients who I think might be trying to take the low road that once a warning letter is on the internet (I call it the "Hall of Shame"), a google search of the name of the CEO will forever after turn up that letter. That is usually enough to deter them from marketing a product that isn't properly cleared.

Good luck!

According to FDA, there is no such thing as a "cosmetic claim" for a device.

A cosmetic product has to meet the following criteria:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance"

In other words, you can make "cosmetic claims" for a cream, ointment, powder, liquid etc, but not a device.

According to FDA, the definition of a device is:

A medical device is defined within the Food Drug & Cosmetic Act as "...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 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."

Years ago I had a non-US client who had had a run-in with FDA over a plastic mask with slot for magnets which were supposed to be placed at the same locations as acupuncture sites. The manufacturer claim was that the mask would cause a lifting effect - same as many cosmetics. He firmly believed that the cosmetic intent freed him from having to get the device cleared, but that little clause in the device definition about affecting the structure in the device definition put it firmly in the jurisdiction of CDRH. FDA insisted in seeing a cleared 510(k) before allowing it to be marketed. He was willing initially, but dropped it after seeing the cost of testing and clearance.

There  are some ugly warning letters on the FDA website and I warn my clients who I think might be trying to take the low road that once a warning letter is on the internet (I call it the "Hall of Shame"), a google search of the name of the CEO will forever after turn up that letter. That is usually enough to deter them from marketing a product that isn't properly cleared.

Good luck!

As I understand it, FDA no longer accepts "split predicates," which it defines as one or more predicates for the technology and one or more predicates for intended use. In other words, predicates that "split" technology and intended use. FDA still accepts multiple predicates "in certain circumstances." From the guidance:

1. Multiple Predicates

A manufacturer may use multiple predicate devices to help demonstrate substantial equivalence in certain circumstances. Manufacturers sometimes choose to do this when combining features from two or more predicate devices with the same intended use into a single new device, when seeking to market a device with more than one intended use, or when seeking more than one indication for use under the same intended use, as described in the examples below.

As I understand it, FDA no longer accepts "split predicates," which it defines as one or more predicates for the technology and one or more predicates for intended use. In other words, predicates that "split" technology and intended use. FDA still accepts multiple predicates "in certain circumstances." From the guidance:

1. Multiple Predicates

A manufacturer may use multiple predicate devices to help demonstrate substantial equivalence in certain circumstances. Manufacturers sometimes choose to do this when combining features from two or more predicate devices with the same intended use into a single new device, when seeking to market a device with more than one intended use, or when seeking more than one indication for use under the same intended use, as described in the examples below.