The history of cosmetic, medical and surgical needling in the US and the associated FDA rules, regulations and approval for sale is complex. Misinformation, half-truths, and outright falsehoods abound. A cursory review of articles, postings on the Internet, and promotional materials by a myriad of manufacturers can be very misleading or outright false. The purpose of this article is only to provide accurate information to our profession and separate fact from fiction.
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.1.2 These actions, taken in multiple correspondence, clearly state that needling devices exceed the premarket notification exemption limitations (21 C.F.R. 878.9 (a) and (b). Continuing, the FDA pointed out that technology and treatment using needling instruments affect the form and function of the body and are, in every sense, medical devices that require clearance under the 510(k) process. 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.
As there is no predicate needling device upon which to base a 510 (k), an application has to be filed with the FDA as a new medical device.
With the growing popularity of needling in the US, the FDA undertook an examination of several devices to determine if they conform to governmental regulations. Recently, two companies1,2 (one with a manual instrument and the other with a motor-driven device) have received warnings or import alerts. The FDA, given its manpower and resources, does not necessarily take action against every brand or device but that does not make them legal. 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. A company 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 1 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 say how likely this is.
Claiming Class 1
A second issue is that many companies claim their needling devices are Class 1 and therefore do not need FDA approval or clearance. This is not true. Specifically, in official correspondence,1,2 FDA rejects the assertion that medical needling is a Class 1 device because a company claims it is akin to dermabrasion or other similar brushes and tools.
The FDA ruled that medical needling devices (both manual and motorized) having a needle length of greater than 0.3mm or adjustable lengths are Class 2 or Class 3 and as such have to go through FDA premarket approval or clearance. If a device has needle length of less than 0.3mm and makes claims that it can alter the form and function of the body, they are also classified the same way. Class 2 and 3 devices obtain FDA approval which, in most cases, requires clinical trials, safety studies and other tests as may be required. No needling devices that are mechanical or have needle lengths longer than 0.3mm have gone through this process and therefore are not legal to be sold in the US. Many brands and Internet sites are selling illegal devices. Many skincare professionals are unwittingly using 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 0.3mm 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.3
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 US. These manufacturers have been banned from selling or importing into the US. 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 being caught.
Another issue concerns needling devices that have needles that are longer than 0.3 mm. These most likely draw blood. In a survey of 50 states conducted in 2014, 46 states responded.6 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 are not aware of the regulations or have been misled by needling instrument manufactures, distributors, and marketing materials including ads in a myriad of professional publications and training courses offered by physicians, aesthetic organizations and at trade shows.
If confronted by a company claiming that their devices are approved for sale in the US, ask them to prove this claim by providing FDA's letter clearing the device under a 510(k) review process or approving it under the premarket approval program. What can be legally 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 coverages, and litigation in the event there are resulting problems should a physician use a device that is not FDA approved. Additional regulation information can be found via footnotes 4,5.
3. FDA letter to DermaCare, July 3, 2014
4. http://www.acessdata.fda.gov.cms ia/importalert 244.htm
6. Survey conducted by DermaConcepts, 2014