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

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

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Language(s):
English
Format:
Text
Subject(s):
Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
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 We have also considered the public comments received on the draft guidance announced in the Federal In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances 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 guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (25 pages)).
NLM Unique ID:
9918504188506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918504188506676