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GUIDANCE DOCUMENT

Regulatory Considerations for Microneedling Devices Guidance for Industry and Food and Drug Administration Staff September 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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

This draft guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and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 clarity on the regulatory pathway to market for microneedling devices.


Submit Comments

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:

Dockets Management
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.