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# Draft Guidewire Test and Labeling Guidance
- URL: https://www.fdaweb.com/draft-guidewire-test-and-labeling-guidance/
- Published: 2018-06-14T12:00:00.000Z
- Updated: 2026-09-15T00:13:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141684

FDA has issued a draft guidance, *Coronary, Peripheral, and Neurovascular Guidewires—Performance Testing and Recommended Labeling*, to assist industry in designing and executing appropriate performance testing to support a premarket notification. It also provides recommendations for content and labeling to include in 510(k) submissions. When final, the [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM610631.pdf?ref=fdaweb.com) will replace a 1/1995 guidance. The agency says the draft is being issued for comment purposes only.