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Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
Health and Human Services Department; Food and Drug Administration: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices. Dated 48 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, from Federal Register API (Office of the Federal Register).
Data as of · Compiled by Zalwin from Federal Register API (Office of the Federal Register)
Free preview: all 9 published fields of this record are shown below. Locked: 62 related FederalRegisterCompliancePulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Final rule |
| Action | Final order. |
| Published | 2026-09-17 |
| Effective | 2026-09-17 |
| Significant | No |
| CFR parts | 21 CFR 892 |
| Summary | The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met: r |
| Document number | 2026-19074 |
| Peer records CSV (63 records) | 🔒 Click to unlock → |
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- Source agency: Federal Register API (Office of the Federal Register)
- Record date: 2026-09-17
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: Federal Register API (Office of the Federal Register) · Last refreshed: Tue, 03 Nov 2026 19:10:06 GMT
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Peer benchmark and outreach value: Health and Human Services Department; Food and Drug Administration and 63 food-and-drug-administration peers
- food-and-drug-administration FederalRegisterCompliancePulse records like this one: 63
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every food-and-drug-administration peer: $12,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Action Urgency Score
- Final rule.
What is the FederalRegisterCompliancePulse record for Health and Human Services Department; Food and Drug Administration?
Health and Human Services Department; Food and Drug Administration published a final rule on 2026-09-17, effective 2026-09-17: Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices.
How does Health and Human Services Department; Food and Drug Administration compare to other FederalRegisterCompliancePulse records?
It is 48 days old; check the official source for later updates before acting. Its Action Urgency Score of 30/100 is modest; treat it as background rather than a priority.
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Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.