Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm429899.htm
Timestamp: 2019-04-18 10:51:02+00:00

Document:
During an inspection of your firm located at 3216 Highland Dr., Suite 200, Salt Lake City, Utah, initiated on July 16, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a Class I micro-needling skin dermabrasion medical device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body of man or other animals.
During the current inspection, we covered importation, manufacturing, and distribution activities pertaining to your Derma Pen micro-needling skin dermabrasion device. We also collected labels, labeling, and promotional materials for the Derma Pen Auto-Microneedle Therapy System. This inspection concluded on July 22, 2014 with the issuance of a two item FDA Form 483.
We acknowledge receipt of your letter dated August 8, 2014, responding to our Form FDA 483, Inspectional Observations, and will verify the implementation and effectiveness of your corrective actions during our next inspection. Your response did not address the concerns discussed with you during the inspection pertaining to your product labeling and promotion.
Our inspection revealed that the Derma Pen is adulterated under section 501(f)(1)(B) of the Act, [21 U.S.C. § 351 (f)(1)(B)], because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, [21 U.S.C. § 360e(a)], or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, [21 U.S.C. § 360j(g)]. The Derma Pen is also misbranded under section 502(o) of the Act, [21 U.S.C. § 352(o)], because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, [21 U.S.C. § 360(k)].
Specifically, devices classified under 21 CFR 878.4820 (Dermabrasion Brush, Powered) are exempt from premarket notification. Generic devices of this type have abrasion substrates which are brushes, rasps and burrs that are intended to abrade and remove layers of the skin via shear force.
The Dermapen is an automated micro-needling device, with a disposable tip cartridge, that uses 11 micro-needles to vertically stamp the skin at high speed. The stamping action of the Dermapen’s vertical tip creates micro-injuries to the skin, stimulating new collagen production. In doing so, these micro-injuries encourage and harness the body’s innate ability to regrow and repair the skin through normal physiological processes. Dermapen is safe and as effective as a fractional laser or intense pulsed light with a significantly short recovery period.
Based on the above, the Derma Pen consists of a stamp of needles that is controlled by a motor in order to make multiple controlled-depth penetrations perpendicularly into the skin while the operator moves the Derma Pen across the skin surface. Unlike Class I exempt powered dermabrasion brushes, the Derma Pen is intended to achieve its clinical effect through the creation of many small puncture wounds in the skin.
At this time, the safe ranges of needle lengths, penetration depths, and speeds of the device are unknown; therefore, FDA has safety concerns regarding the potential for the needles to damage vessels and nerves. FDA previously advised your firm of these concerns, including the Agency’s determination that the Derma Pen exceeded the Class I exemption status, in its response to your firm’s pre-submission (Q140464), dated July 10, 2014.
Because the Derma Pen Auto-Microneedle Therapy System employs a different fundamental scientific technology, it exceeds the limitations described in 21 C.F.R. 878.9(b) and is not exempt from premarket notification.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, [21 U.S.C. § 360(k)], is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at: http://www.fda.gov/MedicalDevices/Device RegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Our office requests that Derma Pen, LLC immediately cease activities that result in the misbranding or adulteration of the Derma Pen Auto-Microneedle Therapy System, such as the commercial distribution of the device for the uses discussed above.
Additionally, we note several products are referenced in your promotional materials as “cosmeceuticals.” Please be aware the Federal Food, Drug and Cosmetic Act (the Act) does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.
Based on claims made in your promotional materials several products including, Derma Pen HA Boost, Derma Pen Photo-Boost, Derma Pen Scar Corrector, Derma Pen Stretch Mark Minimizer, and Derma Pen Stretch Mark Minimizer, would meet the definition of a drug within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)].
Products that meet the definition of a drug, regardless of whether they are also cosmetics, must comply with all applicable drug provisions of the Act and corresponding regulations in order to be legally marketed. Failure to do so could subject products to regulatory action. Additionally, products that are intended as solely cosmetics should not include any claims or other information demonstrating drug intended uses.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of any additional steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Food and Drug Administration, Denver District, P. O. Box 25087, (6th Ave. and Kipling Pkwy., DFC, Bldg 20), Denver, CO 80225-0087, Attention: Matthew R. Dionne, Pharm.D., Compliance Officer. If you have any questions, please contact Dr. Dionne at (303) 236-3064.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 360