Requests that the FDA create an alternative pathway for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices, partially exempting these devices from the premarket notification requirements of section 510(k) of the FD&C Act. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5560

Requests that the FDA create an alternative pathway for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices, partially exempting these devices from the premarket notification requirements of section 510(k) of the FD&C Act.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 28, 2025

Comment Period ClosesFeb 28, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDRH to Rubrum Advising, LLC	Apr 2, 2026	--

Comment Statistics

Total Comments

Keywords

CDRH

Citizen Petition

Rubrum Advising, LLC

Requests that the FDA create an alternative

pathway for radiology Computer-Aided Detection

and/or Diagnosis (CAD) and

Computer-Aided Triage and Notification (CADt)

devices, partially exempting these devices from

Data from Regulations.gov