Docket Number:
FDA-2017-D-4792
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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All written comments should be identified with this document's docket number: FDA-2017-D-4792.