January 30th 2016
There have been a number of instances where companies manufacturing micro needling devices have received warning letters from the Food and Drug administration informing these manufacturers that their products are being marketed illegally or “adulterated” and yet still other companies continue to market similar devices.
In addition, manufacturers of Permanent make up devices (PMUD) continue to legally market their devices which typically appear identical to adulterated micro needling devices.
Furthermore, some manufacturers of micro needling devices appear to be marketing their devices as PMUD instructing their client base to use the devices off label for collagen induction.
This scenario is causing much confusion, so let’s set out some important points that we should be considering.
- By definition, a Medical device is one that is “intended to affect the structure or any function of the body.” Therefore, a micro needling pen that induces collagen induction, clearly by definition alters the structure of the body and is classed as a medical device.
- In talking with the FDA, we believe that currently a micro needling device can only be legally marketed if it does not perforate the stratum corneum, uses blunt needles or tips and is indicated for the purposes of exfoliation of the skin only. All other micro needling devices, where needles pass through the outer epidermal layer of the skin and make claims of collagen induction will require manufacturers to comply with the regulatory classification pathways and actions laid down by the FDA.
What is important here is the definition in terms of the devices indication “where needles pass through the outer epidermal layer of the skin and make claims of collagen induction” A PMUD clearly passes through the stratum corneum but does not make claim to altering the structure or function of the skin, merely it dyes it. The FDA clearly monitor PMUD and tattooing in general, but they do not approve tattoo ink and do not regulate practices in tattoo parlors (the latter is regulated usually by the state or local health departments).
It’s important to remember that manufacturers must decide themselves in terms of the legality of their product. The responsibility for ensuring that a company complies with FDA classification of their devices falls to the company alone. Therefore, a company that switches a device from a micro needling pen indicated for collagen induction to a PMUD can do so as long as they then only market that device for permanent make up. By inferring that the PMUD can be used for collagen induction is illegal but the onus begins to then move to the provider. As a provider it is important to understand the impact of carrying out these procedures when they are being misrepresented by the manufacturers, often the liability will lie with the provider.