USFDA Guidance: Six Finalized Medical Devices Guidelines

USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022).

1. Guidance on: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions

This guidance document provides FDA’s recommendations on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data.

2. Guidance on: Clinical Decision Support Software

This final guidance clarifies focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of the device by the criteria in section 520(o)(1)(E) of the FD&C Act (“Non-Device CDS criteria”) and clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers.

3. Guidance on: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions

This guidance provides FDA’s recommendations regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data.

4. Guidance on: Display Devices for Diagnostic Radiology

This guidance document provides FDA’s recommendations regarding premarket notification (510(k)) submissions for display devices intended for use in diagnostic radiology.

5. Guidance on: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

This guidance communicates how the Agency intends to apply its regulatory oversight to medical device data systems (MDDS), medical image storage devices, and medical image communication devices.

6. Guidance on: Policy for Device Software Functions and Mobile Medical Applications

This guidance communicates how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose computing platforms.