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GUIDANCE DOCUMENT

Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions Guidance for Industry and Food and Drug Administration Staff September 2022

Download the Final Guidance Document
Final
Docket Number:
FDA-2009-D-0503
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides FDA’s recommendations regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data. This guidance applies to CADe devices, including those marketed as a complete package with a review workstation, or as an add-on software embedded within imaging equipment, as an image review platform, or other imaging accessory equipment. The recommendations are intended to promote consistency and facilitate efficient review of 510(k) submissions for CADe devices.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0503.

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