FDA MicroNeedling Draft Guidance

The FDA posted the “Regulatory Considerations for Microneedling Devices, Draft Guidance for Industry and Food and Drug Administration Staff,” today on the FDA website.  This has been a long-anticipated document within the medical device industry, and as a leader in microneedling products, MDPen (www.mdpen.co) is sharing this FDA announcement in an effort to help educate our industry. 

 The FDA states in the announcement: “This draft guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and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. FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.” 

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm575923.pdf

The FDA is allowing for a question period for the next 60 days. Your submission must include Docket No. FDA-2017-D-4792 for “Regulatory Considerations for Microneedling Devices — Draft Guidance for Industry and Food and Drug Administration Staff.’ www.regulations.gov

For additional information, you contact Peter Yang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1551, Silver Spring, MD 20993-0002, 301-796-6477.

MDPen ([http://www.mpen.co) www.mpen.co is a leader in microneedling products, offering both the MDPen Electric and Cordless, and MDPen Serums. Based in Atlanta, Georgia, MDPen distributes products over the US. Contact 888-313-1415 email news@mdpen.co