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# Draft Guide on Peripheral Vascular Atherectomy Devices
- URL: https://www.fdaweb.com/draft-guide-on-peripheral-vascular-atherectomy-devices/
- Published: 2020-07-10T12:00:00.000Z
- Updated: 2026-09-14T16:20:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147173

FDA has made available a [draft guidance](https://www.fda.gov/media/139966/download?ref=fdaweb.com) entitled “Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification \[510(k)\] Submissions.” The document discusses software in atherectomy devices which may include a variety of functions ranging from ensuring that malfunctions that could be hazardous do not occur (e.g., cause injury, erroneous diagnosis, or delay in delivery) to directly controlling device cutting/lasing output. It says that adequate software performance testing provides assurance that the device is safe for the user, operator, and the patient. The guidance recommends that sponsors refer to the FDA’s software guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” to determine software documentation that should be provided in submissions. Additionally, the document addresses risks associated with the presence of bacterial endotoxins, and atherectomy devices should meet pyrogen limit specifications by following recommendations outlined in the agency’s guidance, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.”