Inspections, Compliance, Enforcement, and Criminal Investigations

Bellus Medical 9/13/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204 

 

September 13, 2016
 
2016-DAL-WL-34
WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Joseph L. Proctor, President/CEO
Bellus Medical, LLC.
12001 N. Central Expressway, Suite 250
Dallas, Texas 75243
 
Dear Mr. Proctor:
 
During an inspection of your firm located in Dallas, Texas, from March 21 through March 23, 2016, the United States Food and Drug Administration (FDA) determined that your firm markets and distributes the SkinPen II device (also referred to as SkinPen). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
 
Our inspection, and review of materials collected during the inspection, revealed that the SkinPen II 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 SkinPen II is also misbranded under section 502(o) 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). 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 CFR 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/cdrh/devadvice/3122.html.  The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
Specifically, FDA has reviewed product labeling for the SkinPen II, including your firm’s websites located at http://bellusmedical.com/products/skinpen, http://skinpen.com/ and https://www.youtube.com/watch?v=zWRwhi9Yjrc, brochures, and pamphlets, which revealed that the SkinPen II is an automated, non-surgical microneedling technology device designed for use by licensed healthcare practitioners or individuals directed by practitioners. The device is a microneedling device intended to improve the appearance of fine lines, wrinkles and scars on the face and body by delivering thousands of micro-injuries to the skin to initiate the body’s wound healing process.
 
For example, FDA’s review of the products labeling found the following description of the device:
 
According to the Instructions For Use, the SkinPen II is an automated, non-surgical microneedling technology device designed for use by licensed healthcare practitioners or individuals directed by practitioners. The device incorporates a sterile microneedle cartridge and Bio-Sheath for single use only. The device is a microneedling device intended to improve the appearance of fine lines, wrinkles and scars on the face and body. The SkinPen delivers thousands of micro-injuries to initiate the body’s wound healing process. The device is capable of puncturing the skin to a depth of 2.0 mm with its microneedles. The Microneedle Cartridge contains 12 medical grade 32-gauge needles (http://bellusmedical.com/products/the-advanced-microneedle-cartridge). The variable depth and cordless design provide sufficient versatility to create change in many areas of the body, including the face, neck, chest, arms, hands, legs, abdomen, and back.
 
Based on FDA’s review of the documents collected during the above-referenced inspection, including our review of your firm’s website, the SkinPen II appears to consist 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 SkinPen II across the skin surface. 
 
In general, 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. Unlike the 510(k)-exempt powered dermabrasion brushes, the SkinPen II is a microneedling device intended to achieve its clinical effect through the creation of many small puncture wounds in the skin using an array of needles, and thus raises different questions of safety and effectiveness.
 
Because the safe ranges of needle lengths, penetration depths, and speeds of the device are unknown, FDA has safety concerns regarding the potential for the needles to damage vessels and nerves. FDA is also concerned about infection and cross-contamination due to the reusable portion of the SkinPen II device. Because the SkinPen II employs a different fundamental scientific technology than the devices in 21 CFR 878.4820, it exceeds the limitations described in 21 CFR 878.9(b) and is not exempt from premarket notification.
 
Additionally, the SkinPen II is also misbranded under section 502(a) of the Act, 21 U.S.C. 352(a), in that the labeling of the device, namely its promotional materials on your firm’s websites, contains statements that are misleading in accordance with 21 CFR 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, a testimonial video on your firm’s website states that the SkinPen II is FDA Approved. The SkinPen II was not approved by the FDA.
 
Our office requests that Bellus Medical, LLC., immediately cease activities that result in the misbranding and/or adulteration of the SkinPen II, such as the commercial distribution of the device for the uses discussed above.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. 
 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to: Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: John W. Diehl, Compliance Officer at 214-253-5288.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring your devices into compliance. 
 
 
Sincerely,
/S/                                                           
Edwin Ramos
Acting Dallas District Director
 
 
CC:
Rod Moline, Director
PSQAUE and Consumer Safety Section
Texas Department of State Health Services
8407 Wall Street
Austin, Texas 78714

Page Last Updated: 08/17/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English