Aesthetic medical providers beware: The FDA codified its classification order for microneedling on Friday, likely putting practices using non-cleared devices at greater risk.
“In many medical device liability cases, a doctor is shielded from liability when properly using a cleared and compliant device, since the FDA review and clearance would ensure all likely hazards are controlled,” said Marc C. Sanchez, an FDA attorney who worked on Crown Aesthetics’s microneedling De Novo submission. “That defense is totally washed away when using an unapproved medical device.”
As of March 1, there is only one FDA-cleared microneedling device: SkinPen® by Crown Aesthetics. According to Sanchez, the classification order makes all non-cleared microneedling devices of any kind subject to enforcement actions, such as refusing entry for imported derma rollers and pens as well as issuing warning letters to non-compliant manufacturers.