Description
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.
Scope & Applicability
Product Classes
6Devices applied to radiology images and radiology device data.; Changes to an already cleared CADe device requiring clinical assessment.
CADe devices applied to radiology images and radiology device data
radiological computer-assisted diagnostic devices classified under 21 CFR 892.2060
radiological computer-assisted triage and notification devices
Computer-Assisted Detection Devices Applied to Radiology Images; Computer-Assisted Detection devices applied to radiology images
Computer-Assisted Detection devices applied to radiology images
Stakeholders
5Assist sponsors in the nonclinical evaluation
Clinicians who will use the CADe device.
Qualified individuals involved in the scoring process
Provides clinical judgment and conducts assessments for ClinROs.
Reviewing clinician(s) involved in the truthing process
Regulatory Context
Attributes
7Level of documentation required based on risk; documentation threshold for software functions; Risk-based documentation category; Outcome for software functions with low risk of death or serious injury
conformity with an FDA-recognized standard can help demonstrate that an NGS-based test developer has performed the activities necessary to identify the indications for use; number and types of samples used in the study should be statistically justified for the test’s indications for use; If a modification expands the indications for use beyond aiding in the diagnosis of symptomatic individuals; Acceptable performance levels depend on these
Regulatory standard for 510(k) clearance; demonstration required for 510(k) submission; regulatory standard for 510(k) clearance; Comparison of subject device parameters to predicate 510(k) submission numbers.
Categorization (minor, moderate, major) for software risk.
Former risk classification for CADe devices under the superseded guidance.; Typical risk classification for CADe software
Includes age, ethnicity, race, and sex
Comparison of device features with predicate devices
Identified Hazards
Hazards
2Potential adverse event associated with false negatives.
Potential adverse event associated with false positives.
Related CFR Sections (5)
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead 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 →
- 21CFR892.2050§ 892.2050 Medical image management and processing system.
(a) Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management.Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
Related Warning Letters (8)
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2023-06-20
CGMP/QSR/Medical Devices/Adulterated
Vitang Technology LLC
- 2023-06-06
Medical Devices/Adulterated/Quality System Regulation (QSR)
iRhythm Technologies, Inc.
- 2023-04-25
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Medivance Instruments Ltd.
- 2023-04-19
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Abbott Point of Care Canada Limited
- 2023-02-07
CGMP/QSR/Medical Devices/Adulterated
Getsch+Hiller Medizintechnik GmbH
- 2022-03-08
CGMP/QSR/Medical Devices/PMA/Adulterated
CardioQuip, LLC
- 2020-04-21
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Tenderneeds Fertility LLC
See Also (8)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)
- Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)