‘SkinPen’ Doesn’t Share Dermabrasion Exemption, Warning Letter Says
A March FDA inspection revealed that Bellus Medical marketed and distributed its SkinPen device without approved premarket clearance or an investigational device exemption.
As such, the agency deemed the SkinPen dermabrasion product adulterated because the Dallas-based firm did not notify the FDA that it intended to commercialize its device.
The SkinPen device is an automated, nonsurgical “microneedling” device designed to improve the appearance of wrinkles and scars by delivering “thousands of micro-injuries to the skin,” the warning letter said.
Designed to be used by a licensed practitioner, the device incorporates a sterile microneedle cartridge and bio-sheath for single use. The device punctures the skin to a depth of 2.0 mm.
In general, dermabrasion devices are exempt from premarket notification, the letter said, but the microneedling stamp mechanism that punctures the skin “raises different questions of safety and effectiveness.”
The agency expressed concern about the length of the needles and the potential for damage to vessels and nerves as well as the risk of infection and cross-contamination since the device is reusable.
In addition, the FDA deemed the device misbranded because it was marketed as being “FDA-approved.” The agency said the statement is misleading and asked the firm to immediately cease marketing the device as FDA-approved.
The firm did not respond to a request for comment by deadline.
The FDA Is Watching: What Twitter, Tradeshows and TV Have in Common. The FDA’s focus on promotional activities is no longer limited to magazine and TV ads. It's not much of a leap to begin to think that the FDA has probably created an electronic beehive of monitors and data to keep track of promotional activities of the drug and device markets.