Regulatory considerations for microneedling products : guidance for industry and Food and Drug Administration staff Guidance for industry United States. Department of Health and Human Services United States. Food and Drug Administration Medical Device Legislation Needles -- standards This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 321(h), and is, therefore, subject to the device requirements under the FD&C Act and its implementing regulations. This document also provides information on the regulatory pathway to market for microneedling devices for aesthetic use. [Silver Spring, MD] : Center for Devices and Radiological Health, November 10, 2020 United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Technical Report Text 1 online resource (1 PDF file (11 pages)). nlm:nlmuid-9918249008306676-pdf 9918249008306676 http://resource.nlm.nih.gov/9918249008306676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0