# 2026-15963: FDA Classifies Glucose-Guided Radiation Therapy Device as Safe

2026-15963, Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-08-06, effective 2026-08-06; PRIA reads it as touching household money (as of 2026-08-13).

- Canonical: https://policyrisk.com/federal-register/2026-15963
- As of: 2026-08-13
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-15963
- Title: Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 50708
- Published: 2026-08-06
- Effective: 2026-08-06
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-13

## In one line

FDA Classifies Glucose-Guided Radiation Therapy Device as Safe

## Summary

The Food and Drug Administration (FDA) is classifying the fludeoxyglucose F18-guided radiation therapy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the fludeoxyglucose F18-guided radiation therapy system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

## Effects PRIA read

- Device Classified as Class II: benefit, medium. The FDA has classified the fludeoxyglucose F18-guided radiation therapy system as Class II (special controls). The order is effective August 6, 2026, and the classification was applicable on February 1, 2023. FDA says this classification provides reasonable assurance of safety and effectiveness and…
- Creates Predicate for Future Devices: benefit, medium. Because FDA classified this device via the De Novo process, this device type can serve as a predicate for future devices of the same type. Future sponsors may be able to use the less burdensome 510(k) process instead of De Novo or premarket approval, reducing regulatory burden for device sponsors.
- Premarket 510(k) Notification Required: cost, medium. FDA states that fludeoxyglucose F18-guided radiation therapy systems are subject to premarket notification under section 510(k) of the FD&C Act because FDA has not determined this device type should be exempt under section 510(m).
- New Special Controls: Testing and Labeling: benefit, medium. FDA established special controls (codified at 21 CFR 892.5060) requiring manufacturers to perform specified analyses, design verification/validation, clinical and non-clinical performance testing, electrical and software verification/validation and hazard analysis, user training, and detailed label…

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## Sources
- [2026-15963 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/06/2026-15963/medical-devices-radiology-devices-classification-of-the-fludeoxyglucose-f18-guided-radiation-therapy)
- [2026-15963 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-06/pdf/2026-15963.pdf)

## Related
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- [Next: 2026-15967, Safety Zone; St. Johns River, Jacksonville, FL](https://policyrisk.com/federal-register/2026-15967)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-15963 (as of 2026-08-13).