Regulations.gov document
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection…
Notice · FDA-2025-P-5560 · posted Dec 29, 2025
Key facts
| Document ID | FDA-2025-P-5560-0023 |
|---|---|
| Title | Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices |
| Document type | Notice |
| Subtype | Announcement |
| Agency | FDA |
| Docket | FDA-2025-P-5560 |
| Posted | Dec 29, 2025 |
| Federal Register citation | 90 FR 60730 |
| FR document number | 2025-23901 |
| Comment period opens | Dec 29, 2025 |
| Comments due | Feb 28, 2026 |
| Effective date | Dec 29, 2025 |
At a glance
- 1–9 Pages
- No Open for comment
- 1–9 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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