FDA Issues Draft Guidance on Regulation of Microneedling Products
The Food and Drug Administration issued a new draft guidance document on regulatory considerations for microneedling products, it said. The document includes criteria for determining whether microneedling products, which are instruments with an array of needles or pins stamped or…
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rolled across the skin to facilitate skin exfoliation or treat skin conditions, are considered by FDA to be medical devices. Microneedling devices that do not penetrate living skin and claim only to facilitate exfoliation, improve the appearance of skin, give skin a smoother look and feel or give skin a luminous look would not be considered medical devices by FDA, the draft guidance said. Comments are due Nov. 14.