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# Microneedling Device Guidance Out
- URL: https://www.fdaweb.com/microneedling-device-guidance-out/
- Published: 2017-09-14T12:00:00.000Z
- Updated: 2026-09-14T22:50:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139632

FDA has issued a draft guidance, *Regulatory Considerations for Microneedling Devices*, to assist industry in understanding when a microneedling product is defined as a medical device and thus subject to device requirements under the law and regulations. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM575923.pdf?ref=fdaweb.com) also provides clarity on the regulatory pathway to market for microneedling devices.

Contents include an Introduction, Scope, Definitions, Microneedling Products That Are Devices, Microneedling Products That Are Not Devices, Classification of Microneedling Devices, and Questions and Answers.