Issue Date: November 10, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, General & Plastic Surgery
Status: Final
Regulatory Considerations for Microneedling Products: Guidance for Industry and Food and Drug Administration Staff
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.
Download the Guidance Document
