Derma Pen Warned Over Labeling and Promotion Issues
Derma Pen, a manufacturer of dermabrasion devices, received an FDA warning letter for labeling and promotion problems related to its Derma Pen Auto-Microneedle Therapy System.
According to the Jan. 9 letter posted recently online, the Salt Lake City, Utah, company did not have an approved premarket approval application, investigational device exemption or 510(k) clearance for the Derma Pen, which the agency considers to be a Class I device.
Further, a review of the company’s marketing brochures and handouts revealed claims that Derma Pen is a Class I 510(k)-exempt FDA-registered device, which it is not, the warning letter says. The letter follows a July 16-22, 2014, inspection of Derma Pen’s Salt Lake City, Utah, facility by the FDA’s Denver district office.
The company claimed that the pen is a powered dermabrasion brush, which is exempt from premarket notification. But unlike exempt brushes, the Derma Pen is intended to achieve its clinical effect by creating many small puncture wounds in the skin, the warning letter says.
The FDA says it conveyed its concerns about the safety of the Derma Pen in a response to the company’s July 10, 2014, presubmission.
Derma Pen did not return a request for comment by press time. The warning letter is available at www.fdanews.com/ext/resources/files/01-15/01-22-15-DermaPenWarning.pdf. — Kellen Owings