# 2025-20667: FDA Times Mammography Device Patent Extension Clock

2025-20667, Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective 2025-11-24 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20667
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20667
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52972
- Published: 2025-11-24
- Effective: 2025-11-24
- 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 Mammography Device Patent Extension Clock

## Summary

The FDA has set the official review period for the ENVISION Mammography Platform, which helps extend the patent protecting this medical device. This means the company can get extra time on their patent, giving them more control and potential profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they have until early 2026 to speak up.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENVISION MAMMOGRAPHY PLATFORM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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

- 310-Day Regulatory Review Confirmed: benefit, high. FDA determined the ENVISION MAMMOGRAPHY PLATFORM had a 310-day regulatory review period (0 days testing phase, 310 days approval phase). The PMA was submitted August 31, 2023 and approved July 5, 2024, and this determination establishes the maximum potential length of a patent extension; the applic…
- Public Comment and Petition Deadlines: benefit, low. Anyone may submit comments asking FDA to redetermine the published dates by January 23, 2026, and any interested person may petition FDA regarding the applicant's due diligence during the review period by May 26, 2026.

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## Sources
- [2025-20667 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20667/determination-of-regulatory-review-period-for-purposes-of-patent-extension-envision-mammography)
- [2025-20667 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20667.pdf)

## Related
- [Previous: 2025-20665, Agency Information Collection Activities; Proposed eCollection eComments Reques…](https://policyrisk.com/federal-register/2025-20665)
- [Next: 2025-20668, Determination of Regulatory Review Period for Purposes of Patent Extension; ALT…](https://policyrisk.com/federal-register/2025-20668)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20667 (as of 2026-06-08).