Micro Needling Pen Benefits

FDA Warns – Micro-Needling devices are not exempt Class 1

Dear Practitioners, Please be advised that Derma Pen, LLC is no longer selling its micro-needling devices or micro-needling tips effective April 17, 2015. This notice is a follow-up to and clarification of the letter Derma Pen sent you on February 5th, 2015, which advised you it had received a warning letter from the FDA. The decision to cease sales is based on Derma Pen’s acceptance of the position of the Food and Drug Administration’s Compliance Division that micro-needling devices, such as the Dermapen, require a different method of registration than the industry has been using up to this point. Specifically, in the warning letter of January 9, 2015, the FDA stated that under 21 CFR § 878.4820, powered dermabrasion devices “have abrasion substrates which are brushes, rasps and burrs that are intended to abrade and remove layers of skin via shear force.” Because the Dermapen and similar micro-needling devices use needles to penetrate the skin rather than shearing away layers of skin, a micro-needling device like the Dermapen “…exceeds the limitation of 21 CFR § 878.9 and therefore, is not exempt from premarket notification.” In other words, claims for micro-needling and the scientific technology behind micro-needling are currently outside the scope of the 21 C.F.R § 878.4820 for surgical dermabrasion devices and, therefore, the micro-needling devices are not exempt Class 1 devices. Derma Pen sent a “Response Letter” to the FDA outlining the company’s position and explained its original decision to list micro-needling under 21 C.F.R § 878.4820 and proposed several regulatory tracks under which Derma Pen believed the Dermapen could be sold. The letter also advised the FDA that the original decision was based on expert advice from a respected regulatory consulting firm. On March 30, 2015, the FDA sent Derma Pen its response in the form of a “Regulatory Meeting Request,” in which the FDA responded to the regulatory options Derma Pen provided in its letter. Most importantly, the FDA reiterated its position from the warning letter and concluded that Derma Pen’s micro-needling device “…cannot be marketed within the United States” until the devices have “obtained the appropriate premarket clearance or approval.” 

Derma Pen, LLC respectfully maintains that the original listing did have merit, was done in good faith, was compliant with applicable regulations, and was consistent with the listing of other micro-needling devices marketed in the U.S. Ultimately, however, the regulatory decision belongs to the FDA, and we respect the process as a leader in the industry. As noted in the letter Derma Pen sent to you on February 5th, 2015, the warning letter can be found

at:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429899.htm Consequently, we have accepted the FDA’s position that the underlying scientific technology of micro-needling differs from its current registration for “dermabrasion” and therefore is not an exempt Class 1 device.

Accordingly, Derma Pen agreed to stop selling micro-needling devices and tips in the USA. 

MARKET ANALYSIS It’s only natural that the FDA would begin enforcement of its recent decision with Derma Pen because Derma Pen is an industry leader and had reached out to the FDA last year. There are, however, at least ten other companies that distribute micro-needling devices in the United States, eight of which are also using the same registration (i.e., as an exempt Class 1 device). While we have no direct information about how the FDA will respond to other companies, but it seems logical to expect the FDA to send similar warning letters to companies using micro-needling technology and that the FDA will require them to cease sales until they obtain a new classification from the FDA.DISCONTINUED SALES At this time, it appears that there is no approved regulatory manner for selling micro-needling devices in the United States other than to request a classification opinion from the FDA and to follow the regulatory steps that such an opinion would require. If that changes, we will of course let you know. But in the meantime, we regret to inform you that all pending sales of devices and tips have been canceled.

No customers will be charged for any pending product sales or orders. Similarly, Derma Pen, LLC will no longer service products or process returned products in exchange for new products. The FDA has determined that this practice would impermissible perpetuate the continued use of the micro-needling device. Likewise, Derma Pen, LLC has canceled. all plans to sell the MDerma FDS. Derma Pen is therefore canceling all existing or pending sales of the MDerma FDS in order to comply with the FDA’s decision until the proper regulatory path is granted by the FDA We are sorry for any inconvenience this may cause you. If you have customer concerns or questions please direct them to Derma Pen’s phone line at 1-800-981-5402 or email info@dermapen.com If you have questions about other micro-needling devices that are currently being sold in the USA you can contact:Matthew R. Dionne, Pharm.D., BCPS, MBA Commander U.S. PHS United States Food and Drug Administration Compliance Officer Denver District Office PO Box 25087 Denver, CO 80225 303-236-3064 Derma Pen, LLC wishes to thank you for your business and support you have shown over the past several years. Sincerely, Derma Pen, LLC Management

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