Regulatory Considerations for Microneedling Devices
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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This draft guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and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.
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:
Division of Dockets Management (HFA- 305)
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.