# 2025-20668: FDA Times Patent Clock for Altius Nerve Zapper System

2025-20668, Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective Anyone with knowledge that any of the dates as published are incorrect may submit comments and ask for a redetermination by January 23, 2026. Any interested person may petition FDA for a determination regarding whether the applicant acted with due diligence during the regulatory review period by May 26, 2026. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20668
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20668
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52974
- Published: 2025-11-24
- Effective: Anyone with knowledge that any of the dates as published are incorrect may submit comments and ask for a redetermination by January 23, 2026. Any interested person may petition FDA for a determination regarding whether the applicant acted with due diligence during the regulatory review period by May 26, 2026.
- Comments close: 2026-01-23
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Times Patent Clock for Altius Nerve Zapper System

## Summary

The FDA has set the official review period for the ALTIUS Direct Electrical Nerve Stimulation System, helping the company extend its patent protection. This means the device maker could get more time to keep others from copying their invention. If you think the dates are wrong or want to challenge the company’s review speed, you have until early 2026 to speak up.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALTIUS Direct Electrical Nerve Stimulation System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

## Effects PRIA read

No economic effects identified for this document.

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## Sources
- [2025-20668 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20668/determination-of-regulatory-review-period-for-purposes-of-patent-extension-altius-direct-electrical)
- [2025-20668 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20668.pdf)

## Related
- [Previous: 2025-20667, Determination of Regulatory Review Period for Purposes of Patent Extension; ENV…](https://policyrisk.com/federal-register/2025-20667)
- [Next: 2025-20670, Proposed Information Collection Request; Comment Request; NESHAP for Radionucli…](https://policyrisk.com/federal-register/2025-20670)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20668 (as of 2026-06-08).