Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

One of my clients is looking forward to launching hyaluronic acid dermal filler pre-filled syringes as cosmetics in the US. Though it will be in the cosmetics space, but pre-filled syringes, will my client require FDA approval? Thank you. 

Dermal fillers, whether absorbable or non-absorbable, are regulated as medical devices, regardless of whether supplied in syringes or vials. Your client may need expert advice to prepare the appropriate documentation with regard to supplier control, sterility assurance, and so on.

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

https://www.fda.gov/media/147036/download

https://www.fda.gov/media/147037/download

https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers

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Anne LeBlanc
United States
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Original Message:
Sent: 13-Dec-2023 10:46
From: Anonymous Member
Subject: dermal filler pre filled syringes

This message was posted by a user wishing to remain anonymous

One of my clients is looking forward to launching hyaluronic acid dermal filler pre-filled syringes as cosmetics in the US. Though it will be in the cosmetics space, but pre-filled syringes, will my client require FDA approval? Thank you. 

Hi Anon.

To add on to Anne's response - there is almost no way that I know of that would allow the provision of dermal filler in a syringe in the cosmetics space in the US.  Generally, FDA has viewed cosmetics as "topical" applications.  The fact that the product is being injected into the skin itself would come with other issues including things like sterility testing (note that cosmetics in the US are not required to be sterile but injectables generally are) and would also come with the requirement that the product be injected under the supervision of professionals (at least in my opinion on this point).

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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 13-Dec-2023 14:10
From: Anne LeBlanc
Subject: dermal filler pre filled syringes

Dermal fillers, whether absorbable or non-absorbable, are regulated as medical devices, regardless of whether supplied in syringes or vials. Your client may need expert advice to prepare the appropriate documentation with regard to supplier control, sterility assurance, and so on.

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

https://www.fda.gov/media/147036/download

https://www.fda.gov/media/147037/download

https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 13-Dec-2023 10:46
From: Anonymous Member
Subject: dermal filler pre filled syringes

This message was posted by a user wishing to remain anonymous

One of my clients is looking forward to launching hyaluronic acid dermal filler pre-filled syringes as cosmetics in the US. Though it will be in the cosmetics space, but pre-filled syringes, will my client require FDA approval? Thank you.