# 117-hr-8299: To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.

117-hr-8299, To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan., is a 117th Congress bill sponsored by Rep. Bilirakis, Gus M. [R-FL-12] (R-FL); status Referred to the House Committee on Energy and Commerce. (as of 2025-11-18).

- Canonical: https://policyrisk.com/legislation/117-hr-8299
- As of: 2025-11-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 117-hr-8299
- Congress: 117
- Title: To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
- Status: Referred to the House Committee on Energy and Commerce.
- Introduced: 2022-07-07
- Sponsor: Rep. Bilirakis, Gus M. [R-FL-12] (R-FL)
- Cosponsors: 7
- Policy area: Health
- Touches household money: no
- Last recorded action: 2025-11-18

## Summary

This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.

## Cosponsors (7)

- Rep. O'Halleran, Tom [D-AZ-1] (D-AZ), 2022-07-07T00:00:00.000Z
- Rep. Kuster, Ann M. [D-NH-2] (D-NH), 2022-07-28T00:00:00.000Z
- Rep. Cárdenas, Tony [D-CA-29] (D-CA), 2022-07-28T00:00:00.000Z
- Rep. Craig, Angie [D-MN-2] (D-MN), 2022-07-29T00:00:00.000Z
- Rep. Rutherford, John H. [R-FL-5] (R-FL), 2022-09-29T00:00:00.000Z
- Rep. DeGette, Diana [D-CO-1] (D-CO), 2022-09-29T00:00:00.000Z
- Rep. Neguse, Joe [D-CO-2] (D-CO), 2022-11-14T00:00:00.000Z

## Related bills

- 117-hr-1667: Dr. Lorna Breen Health Care Provider Protection Act
- 117-hr-3537: Accelerating Access to Critical Therapies for ALS Act
- 117-hr-263: Big Cat Public Safety Act
- 117-hr-1057: Greatest Generation Commemorative Coin Act
- 117-hr-8800: Supporting Medicare Providers Act of 2022
- 117-hr-6015: Benjamin Berell Ferencz Congressional Gold Medal Act

## Sources
- [117-hr-8299 on Congress.gov](https://www.congress.gov/bill/117th-congress/house-bill/8299)

## Related
- [117-hr-1667: Dr. Lorna Breen Health Care Provider Protection Act](https://policyrisk.com/legislation/117-hr-1667)
- [117-hr-3537: Accelerating Access to Critical Therapies for ALS Act](https://policyrisk.com/legislation/117-hr-3537)
- [117-hr-263: Big Cat Public Safety Act](https://policyrisk.com/legislation/117-hr-263)
- [117-hr-1057: Greatest Generation Commemorative Coin Act](https://policyrisk.com/legislation/117-hr-1057)
- [117-hr-8800: Supporting Medicare Providers Act of 2022](https://policyrisk.com/legislation/117-hr-8800)
- [117-hr-6015: Benjamin Berell Ferencz Congressional Gold Medal Act](https://policyrisk.com/legislation/117-hr-6015)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/117-hr-8299 (as of 2025-11-18).