USA – FDA finalizes guidance on microneedling devices

The US Food and Drug Administration (FDA) on Monday finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.
 
The final guidance, which comes more than three years after being released in draft form, has been revised to reflect the classification of microneedling devices for aesthetic use as Class II devices in response to a De Novo classification request for Bellus Medical’s SkinPen. Since issuing the classification order, FDA has cleared several other microneedling devices including Esthetic Education’s Skinstylus Sterilock Microsystem and Refine USA’s Rejuvapen NXT. (RELATED: FDA steps in to regulate microneedling devicesRegulatory Focus 14 September 2017).
 
“To date, the FDA has only granted marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. The FDA may not have reviewed the use of certain microneedling devices for all locations in the body,” FDA explains