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Road to Regulation: Microneedling Devices Defined by FDA

Wednesday, October 25, 2017   (0 Comments)
Posted by: Aly Boeckh
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Microneedling devices came under the lens in a new draft guidance issued by the U.S. Food and Drug Administ­ration (FDA) on Sept. 15, 2017. The guidance differen­tiated between medical and esthetic devices used for microneedling and identified which products are subject to potential regulation.

Medical Devices

Products that penetrate beyond the stratum corneum into living layers of the skin meet the medical device definition, according to the guidance. A device’s needle length, arrangement and sharpness, along with degree of control, will be considered by the FDA. Also included in this definition are devices claiming to:

  • Treat scars (e.g., acne scars, atrophic scars, hypertrophic scars or burn scars);
  • Treat wrinkles and deep facial lines;
  • Read more at Skin Inc >> 

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