Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff

Technical performance assessment of quantitative imaging in radiological device premarket 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, June 16, 2022
Language(s):
English
Format:
Text
Subject(s):
Device Approval
Technology, Radiologic -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
The Food and Drug Administration (FDA) is issuing this guidance to provide recommendations for manufacturers about the information that should be included in premarket submissions for radiological devices that include quantitative imaging functions. This guidance document is broadly applicable to a variety of premarket submission types (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications and De Novo requests) for these devices and should be used in conjunction with any existing device- and submission-specific guidance documents. Overall premarket submission requirements and recommended information to provide can differ depending on the submission type. Additional information on each submission type can be found on the FDA’s Premarket Submissions webpage.1 Questions regarding the regulatory status or requirements should be addressed to the appropriate review division through the Q-Submission process; see “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff.” This guidance document clarifies that, in general, manufacturers preparing premarket submissions for radiological devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand, and interpret the values provided by the quantitative imaging functions. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance 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 (17 pages))
NLM Unique ID:
9918470188306676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918470188306676