The US Food and Drug Administration (FDA) has changed the microneedling device classification for aesthetic use to a class II, rather than the automatic class III assignment.
According to the FDA, a microneedling device is identified as, “A device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.”
According to the FDA, classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The FDA statement said, ‘We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens’.
The FDA also noted the risks associated with microneedling devices and the measures required to mitigate these. Among others, these included adverse tissue reaction (biocompatibility evaluation and labeling) and cross-contamination and infection (sterilisation validation, reprocessing validation, non-clinical performance testing, shelf life testing, and labeling).
Dr Selena Langdon, founder and medical director at Berkshire Aesthetics, who is experienced in performing microneedling treatments in the UK, commented, “I believe the FDA’s decision to classify microneedling, in all forms, as a class II medical device is correct. While the UK standards are not as strict, the risks to health associated with the use of microneedling devices should not be ignored. I encourage other practitioners to consider the impact that this decision has on the safety of the equipment that they use. I have chosen to use the only FDA cleared device in my practice (SkinPen Precision), and believe it is the right choice to protect my patients in terms of their health and safety.”
For more information on the classification, click here.