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.
For more details on our products and services, please feel free to visit us at micro needling benefits, microneedling for hair loss & micro needling side effects ” 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.
Published on Feb 17, 2017
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