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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 July 2012

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

This guidance document provides recommendations to industry, systems and service providers,consultants, FDA staff, and others regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data (often referred to as “radiological data” in this document). CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities (i.e., combine values, measurements, or features extracted from the patient radiological data) and are intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the intended user (i.e., a physician or other health care professional), referred to as the “clinician” in this document. We have considered the recommendations on documentation and performance testing for CADe devices made during the Radiology Devices Panel meetings on March 4-5, 2008 and November 17-18, 2009. We have also considered the public comments received on the draft guidance announced in the Federal Register on October 21, 2009 (74 FR 54053).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.


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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.