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# Guidance on Medical Device Accessories
- URL: https://www.fdaweb.com/guidance-on-medical-device-accessories/
- Published: 2017-01-04T12:00:00.000Z
- Updated: 2026-09-14T21:57:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137637

FDA has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429672.pdf?ref=fdaweb.com) on “Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types.”The document is intended to describe FDA’s policy concerning the classification of accessories and discuss the application of that policy to devices that are commonly used as accessories to other medical devices. In addition, it explains what devices FDA generally considers an “accessory” and encourages use of the *de novo* classification process to allow manufacturers and other parties to request risk- and regulatory control-based classification of new accessories.