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GUIDANCE DOCUMENT

Regulatory Considerations for Microneedling Products Guidance for Industry and Food and Drug Administration Staff November 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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