The history of cosmetic, medical, and surgical needling in the U.S. and the associated Food and Drug Administration (FDA) rules, regulations, and approval for sale is complex. A cursory review of articles, postings on the Internet, and promotional materials by a myriad of manufacturers can be very misleading or outright false as with many other esthetic technologies. The purpose of this article is to separate fact from fiction and to provide accurate information for the medical spa industry. Parts of this article have been presented at the Society of Plastic Surgical Skin Care Specialists (SPSSCS) meeting held in May in Montreal and published elsewhere.
The goal of this article is to clarify the following key terms and questions directly related to needling and the FDA. It is important to note that this article only applies to the United States as other countries have taken different positions on skin needling.
Is the device (manual or motorized) cleared for sale and use by the FDA? If you cannot get this in writing on FDA letterhead from the manufacturer or distributor on the specific device, the device is not legal. As one of our presidents used to say “Trust but verify.”
Many manufacturers are working with the FDA on obtaining approval, including our company. A number of studies that take time are in the planning stages or already underway. Additionally, the fact that the FDA has not taken action against a specific company or device does not make it legal. At present, only devices with needle lengths less than .3 mm are allowed for sale provided they make no medical claims. If medical claims are asserted, the device is not legal at this time.
We would be remiss if we did not point out that we are advocates of skin needling and believe it is an efficacious and safe treatment. We also are associated with Des Fernandes M.D., one of the leading experts and modern professional generator of skin needling. Nevertheless, in dealing with the FDA on this issue, the agency has made it abundantly clear that there is a myriad of misinformation and unapproved devices being sold and advertised in the U.S. They cautioned my company and others to cease and desist from selling needling devices until such time as we obtain proper clearance or approval. We were also confronted with the fact that individuals using unapproved devices are exposing themselves to potential problems that can affect licensing and give rise to legal issues. Our company, as are others, is working with the FDA to determine the way forward with the goal of ensuring a range of needling devices can be legal in the U.S.
It is important to note that the FDA has not published any regulation exactly on point for needling. It has, however, taken action against companies for selling unapproved medical devices. These actions, taken in multiple correspondence, clearly state that needling devices exceed the premarket notification exemption limitations. Continuing, the FDA pointed out that technology and treatment using needling instruments effect the form and function of the body and are, in every sense, medical devices that require premarket clearance.
The FDA regulates medical products based on intended use which includes reviewing a product’s design and action, claims stated in product labels, inserts, advertising, on the Internet, promotional materials, and consumer perception. With the advent of growing popularity of needling in the U.S., the FDA undertook an examination of several devices to determine if they conform to governmental regulations and has issued warnings or import alerts. The FDA regulates devices. It does not regulate practitioners and what they can or cannot due under the scope of their license. Everyone should check with the appropriate licensure body in their state to ensure what they can or cannot do. It is incumbent on all of us to conduct our due diligence to ensure we are in compliance with applicable device and licensing regulations.
To help better understand this issue one has to be able to learn the difference between FDA registered, FDA cleared or approved for sale, and the definition of a medical claim.
Anyone can get a device or instrument listed (many call this registered) by completing a simple form. Acompany that says they are registered and their needling device is listed does not mean it is approved nor does it connote that it is legal to be sold or used in the US. Registration/listing has nothing to do with whether a device or instrument has been cleared for sale. Most companies claim their devices are listed and try to pass this off as approved. Nothing can be farther from the truth and the FDA considers such attempts unlawful ( 21 C.F.R. 807.39).
The fact that a company lists its device as Class One does not mean the FDA agrees with that designation. The act of listing a device does not carry any material meaning in relation to being approved or cleared for sale. Establishments that are selling unapproved needling instruments are subject to penalties, some very severe, for selling or using illegal instruments as well as open to litigation from staff, patients, and others. No one can predict how likely this is.
Claiming Class One
A second issue is that many companies claim their needling devices are Class One and therefore do not need FDA approval or clearance. This is not true. The FDA ruled that medical needling devices (both manual and motorized) as having a needle length of more than .3 mm or adjustable lengths are Class Two or Class Three and as such have to go through FDA premarket approval or clearance. If a device has needle length of less than .3mm and makes claims that it can alter the form and function of the body, they are also classified the same way. In order for Class Two and Three devices to obtain FDA approval most cases require clinical trials, safety studies, and other tests. No needling devices that are mechanical or have needle lengths longer than .3 mm have gone through this process and therefore are not legal to be sold in the U.S. Many brands and Internet sites are selling illegal devices. A critical issue in classification also centers on claims or marketing materials that state that an instrument or device can alter the form and function of the body.
Cosmetic needling instruments must have a needle length of .3 mm or less and make no medical claims in any manner. If a device makes no medical claims, focusing only on improving the appearance of the skin and does not pass the stratum corneum, it does not fall under the jurisdiction of the FDA. Yet, you can find illegal devices on E-bay and Amazon as well as prescription topical anesthetic creams and pills. As soon as these get removed from sale, others pop up. It is like playing the child’s game wack –a mole.
The FDA has gone to great lengths to try to ban the import of medical needling instruments. Many of these are made in Asia and are marketed under several brand names in the U.S. These manufacturers have been banned from selling or importing into the U.S. The problem of FDA enforcement comes into play as these devices are entering the US either illegally or under brand names distinct from the banned manufacturers. Eventually, these brands are caught.
Another issue concerns needling devices that have needles that are longer than .3 mm. These most likely draw blood. In a survey of 50 states conducted in 2014 by Dermaconcepts, 46 states responded. Every single response indicated that it is illegal for estheticians to use any instrument that has needles that can pass the stratum corneum or use devices and instruments that run afoul of FDA regulations. Many skincare professionals may not be aware of the regulations or have been misled by needling instrument manufactures, distributors and marketing materials. This issue is even more confusing as a number of companies, physicians and organizations are teaching medical needling, granting certificates and advocating specific devices. This is far different from organizations that are focused on providing information on needling technology, how it works, and its efficacy. The more medical needling education offered, the better.
If confronted by a company claiming that its devices are approved for sale in the U.S., ask them to prove this claim by providing FDA’s letter clearing the device for sale. What can legally be performed by a licensed physician is up to each state’s medical licensing board and is separate from whether the device itself is legal. But, that is another quite complex problem involving liability, practice insurance coverage, and litigation in the event there are resulting problems should a physician use a device that is not FDA approved.