Regulatory Open Forum

Hello fellow Rappers,

Happy Friday!! As is always the case, we are in the process of launching a new device that while intended solely for cosmetic purposes, we have seen a few that have been cleared by the agency, using micro-current technology, to tone and improve appearance. While improving appearance is cosmetic (appearance of fine lines, etc), toning and lifting would be considered a change to structure.  

Micro-current is linked to anti-aging benefits (from a non-cosmetic perspective), but there are several micro-current devices that claim to help with anti-aging from a cosmetic standpoint.  Of course we would like steer clear of having to file a 510(k).  The question is whether the use of micro-current technology alone puts us under FDA's purview, or can we use micro-current technology and not claim any change to the structure of the skin/body or treatment such as removal of wrinkles?  I guess we are wanting to know if micro-current technology, albeit the claim(s), makes the device medical in nature.

Any feedback would be great. 


Thank you,
Laura

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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Given, that there are some products with micro current technology that are medical devices and some that are marketed as cosmetic, I would also review warning letters. It is quite possible that the Intended Use is the indeed the defining the line.

It may also be prudent to understand if there is a technological feature that therapeutically resolves the cosmetic marketed products from the medical devices. 

Overall, I suspect if none of the above further resolves, that there were some companies who also did not want to market the product as a medical device and simply adjusted their claims. It is a decision of risk.

------------------------------
Timothy Kline, Ph.D., RAC
Senior Manager
------------------------------

Original Message:
Sent: 02-Nov-2018 16:16
From: LAURA HOSHUE
Subject: Micro-current technology

Hello fellow Rappers,

Happy Friday!! As is always the case, we are in the process of launching a new device that while intended solely for cosmetic purposes, we have seen a few that have been cleared by the agency, using micro-current technology, to tone and improve appearance. While improving appearance is cosmetic (appearance of fine lines, etc), toning and lifting would be considered a change to structure.

Micro-current is linked to anti-aging benefits (from a non-cosmetic perspective), but there are several micro-current devices that claim to help with anti-aging from a cosmetic standpoint.  Of course we would like steer clear of having to file a 510(k).  The question is whether the use of micro-current technology alone puts us under FDA's purview, or can we use micro-current technology and not claim any change to the structure of the skin/body or treatment such as removal of wrinkles?  I guess we are wanting to know if micro-current technology, albeit the claim(s), makes the device medical in nature.

Any feedback would be great.


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Thank you so much Timothy.  That is indeed the struggle.  Please explain to me so I can better understand what you mean when you say that there may be a technological feature that therapeutically resolves the cosmetic marketed products from the medical devices.  How would one determine that? 

Please advise.


Thank you,
Laura 


------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 03-Nov-2018 05:40
From: Timothy Kline
Subject: Micro-current technology

Given, that there are some products with micro current technology that are medical devices and some that are marketed as cosmetic, I would also review warning letters. It is quite possible that the Intended Use is the indeed the defining the line.

It may also be prudent to understand if there is a technological feature that therapeutically resolves the cosmetic marketed products from the medical devices.

Overall, I suspect if none of the above further resolves, that there were some companies who also did not want to market the product as a medical device and simply adjusted their claims. It is a decision of risk.

------------------------------
Timothy Kline, Ph.D., RAC
Senior Manager

Original Message:
Sent: 02-Nov-2018 16:16
From: LAURA HOSHUE
Subject: Micro-current technology

Hello fellow Rappers,

Happy Friday!! As is always the case, we are in the process of launching a new device that while intended solely for cosmetic purposes, we have seen a few that have been cleared by the agency, using micro-current technology, to tone and improve appearance. While improving appearance is cosmetic (appearance of fine lines, etc), toning and lifting would be considered a change to structure.

Micro-current is linked to anti-aging benefits (from a non-cosmetic perspective), but there are several micro-current devices that claim to help with anti-aging from a cosmetic standpoint.  Of course we would like steer clear of having to file a 510(k).  The question is whether the use of micro-current technology alone puts us under FDA's purview, or can we use micro-current technology and not claim any change to the structure of the skin/body or treatment such as removal of wrinkles?  I guess we are wanting to know if micro-current technology, albeit the claim(s), makes the device medical in nature.

Any feedback would be great.


Thank you,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------