# 2025-11026: FDA Patent Clock Ticks for a Device Named Smart Assist

2025-11026, Determination of Regulatory Review Period for Purposes of Patent Extension; [IMPELLA RP FLEX WITH SMART ASSIST], is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Anyone may submit comments asking for redetermination by August 15, 2025. Any interested person may petition FDA regarding whether the applicant acted with due diligence by December 15, 2025.; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11026
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11026
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; [IMPELLA RP FLEX WITH SMART ASSIST]
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25308
- Published: 2025-06-16
- Effective: Anyone may submit comments asking for redetermination by August 15, 2025. Any interested person may petition FDA regarding whether the applicant acted with due diligence by December 15, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Patent Clock Ticks for a Device Named Smart Assist

## Summary

The FDA has officially set the review period for the IMPELLA RP FLEX WITH SMART ASSIST medical device, which helps the company extend its patent protection. If you think the dates are wrong or want to challenge the company's review efforts, you have until mid-2025 to speak up. This means the company could get more time to protect their invention, potentially affecting competition and innovation timing.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMPELLA RP FLEX WITH SMART ASSIST 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

- FDA finds 212‑day review period: benefit, medium. FDA determined the regulatory review period for IMPELLA RP FLEX WITH SMART ASSIST is 212 days (0 days testing phase and 212 days approval phase). The applicant (Abiomed Inc.) submitted a PMA on March 31, 2022, the PMA was approved on October 28, 2022, and the applicant seeks 212 days of patent term…
- Opportunity to challenge review dates: benefit, low. If you think any published dates are incorrect, you may submit electronic or written comments asking for a redetermination by August 15, 2025. Additionally, any interested person may petition FDA under 21 CFR 60.30 to challenge whether the applicant acted with due diligence during the regulatory re…
- Device approval and clinical indication confirmed: benefit, high. FDA approved IMPELLA RP FLEX WITH SMART ASSIST for marketing, indicated to provide temporary right ventricular support for up to 14 days in patients with a body surface area >= 1.5 m2 who develop acute right heart failure or decompensation after specified events. FDA verified the PMA approval date…

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## Sources
- [2025-11026 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11026/determination-of-regulatory-review-period-for-purposes-of-patent-extension-impella-rp-flex-with)
- [2025-11026 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11026.pdf)

## Related
- [Previous: 2025-11025, Determination of Regulatory Review Period for Purposes of Patent Extension; POM…](https://policyrisk.com/federal-register/2025-11025)
- [Next: 2025-11027, Agency Information Collection Activities: Submission for OMB Review; Comment Re…](https://policyrisk.com/federal-register/2025-11027)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11026 (as of 2026-11-02).