Description
This guidance document provides FDA's recommendations on the information, technical performance assessment, and user information that should be included in a premarket submission for radiological devices that include quantitative imaging functions. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of premarket submissions for radiological devices that include quantitative imaging functions.
Scope & Applicability
Product Classes
1devices that include quantitative imaging functions; premarket submission for radiological devices that include quantitative imaging functions; Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Stakeholders
4Entity responsible for submitting NDINs
studies involving multiple clinicians and a range of clinical use scenarios.
Image acceptance activities performed manually by a trained user
information for the end user to obtain, understand, and interpret values; tasks that are the responsibility of the end user.
Regulatory Context
Attributes
10Evidence of a new intended use based on communications
A component of precision validation; Reproducibility is assessed by means of an interlaboratory trial
Systematic errors introduced due to sampling or measurement.
Primary sources of variability affecting the quantitative imaging output
Performance characteristic assessed via linearity experiment
Closeness of agreement between a series of measurements from multiple samplings.; Performance characteristic measured by intermediate precision; Performance characteristic to be validated
Specific image acquisition parameter ranges
Specific image acquisition parameter ranges
Specific image acquisition parameter ranges
Uncertainty should be included in the performance specifications for all quantitative imaging functions
Identified Hazards
Hazards
4Quantitative imaging values are usually subject to systematic error
Typical sources of uncertainty and harm in a process.
Quantitative imaging values are usually subject to random variation
Quantitative imaging values derived from medical images may be affected by multiple sources of error; Known and potential sources of substantial measurement error should be listed.
Related CFR Sections (2)
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
Related Warning Letters (1)
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
See Also (8)
- Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 345.200 Diaphragms - Rx Devices (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)
- Guidance for the Content of Premarket Notifications for Ureteral Stents (Status: Final)