December 31st 2015
The current micro needling market is in some confusion here in the US. 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 other companies continue to market their devices. This has led to much confusion amongst physicians and estheticians with some companies withdrawing their products and or consumables from sale while others continue to freely promote their devices claiming the benefits of collagen induction.
To understand why and how this is suddenly happening we need to look back at the recent history of these devices.
Of late, manufacturers of micro needling pens classified their products as a Class I device, akin to microdermabrasion machines, circumventing the need for FDA clearance. As the popularity of these devices increased and more manufacturers entered the space, the FDA embarked upon a review of several devices resulting in FDA warning letters to some manufacturers, stating that the FDA did not agree with such classification and requesting that they (the manufacturers) remove their devices and associated consumables from sale in the US whilst they prepare and document evidence that would allow them to comply to the correct regulatory pathway.
Why then you may ask are some companies still marketing and selling micro needling devices and associated consumables (micro needles)? Technically these companies, aware of the FDA position on micro needling devices are marketing the devices and consumables illegally. The Food and Drug administration does not have infinite resources and therefore cannot possibly regulate all manufacturers or importers of micro needling devices, rather these manufacturers or importers should be conducting their own internal reviews to ensure that they comply with the current regulatory requirements.
What of the provider, the physician or esthetician? Unintentionally they are most probably using an illegal device.
The current regulatory landscape.
By definition, a Medical device is one that is “intended to affect the structure or any function of the body.” It has always surprised me that a device that penetrated past the stratum corneum, causes pin point, controlled bleeding and subsequent collagen formation could ever be classified as a class I device, likened to a microdermabrasion device.
It’s reasonable to assume therefore that micro needling devices will be classified as either class II or III and will require to follow either a de novo classification or a premarket approval (PMA) to market “clearance” or “approval” respectively.
Some manufacturers recently explained to me that their devices were “listed” or “registered” with the FDA and that they can legally market their devices. This is not true. Listing or registering really only means that the company has completed a simple on line registration form, it does not mean that the device can be legally sold for the indication that it is claiming use for.
Some manufacturers have rightly removed from sale their product line or adulterated consumables whilst they go about collecting the necessary data that is required by the FDA for a suitable submission to gain marketing clearance or approval. Others have continued to sell product in the knowledge that by definition they are doing so illegally.
In talking with the FDA, I 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.