# 119-hr-5158: Fair Price Device Act

119-hr-5158, Fair Price Device Act, is a 119th Congress bill sponsored by Rep. Scholten, Hillary J. [D-MI-3] (D-MI); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-hr-5158
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-5158
- Congress: 119
- Title: Fair Price Device Act
- Status: introduced
- Introduced: 2025-09-04
- Sponsor: Rep. Scholten, Hillary J. [D-MI-3] (D-MI)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## Summary

**Raises the evidentiary bar for generic drugs paired with medical devices.** This bill would require device-specific information and, where applicable, comparative and non-comparative human factors studies to show a generic drug used with a device can be expected to have the same clinical effect and safety profile as the listed drug when used under the drug's labeling. - Patients and caregivers: Aims to make drug-plus-device products safer and more predictable by asking for data that shows the combined product performs like the listed product. - Generic drug makers: Would need to submit device performance, compatibility, delivery information, and comparative analyses showing any user-interface differences do not change clinical effect or safety. - Device manufacturers and product developers: May need to provide data on device changes and user-interface differences when a device is paired with a new generic drug. - FDA (the Secretary): Gains authority to determine what device-specific information and studies are required or appropriate to establish equivalence.

## Cosponsors (1)

- Rep. Maloy, Celeste [R-UT-2] (R-UT), 2025-09-15T00:00:00.000Z

## Provisions PRIA read

- New rules for generic drug-device combinations: mixed, medium. If enacted, makers of generic drugs used with devices would need extra proof. Proof could include device performance, compatibility, delivery, and human factors studies. Applicants would also compare user interfaces and show the same safety and effect as the listed product. The FDA could judge an a…

## Related bills

- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-6900: American Affordability Act of 2025
- 119-hr-4669: FEMA Act of 2025
- 119-hr-7977: Energy Bills Relief Act
- 119-hr-4393: DIGNIDAD (Dignity) Act of 2025
- 119-hr-2725: Affordable Housing Credit Improvement Act of 2025

## Sources
- [119-hr-5158 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/5158)

## Related
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-6900: American Affordability Act of 2025](https://policyrisk.com/legislation/119-hr-6900)
- [119-hr-4669: FEMA Act of 2025](https://policyrisk.com/legislation/119-hr-4669)
- [119-hr-7977: Energy Bills Relief Act](https://policyrisk.com/legislation/119-hr-7977)
- [119-hr-4393: DIGNIDAD (Dignity) Act of 2025](https://policyrisk.com/legislation/119-hr-4393)
- [119-hr-2725: Affordable Housing Credit Improvement Act of 2025](https://policyrisk.com/legislation/119-hr-2725)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-5158 (as of 2026-04-21).