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H.R. 7679House117th Congress (2021-2023)In Committee

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

Sponsored by Lizzie FletcherRep. Lizzie Fletcher (D-TX)
Introduced May 6, 2022

AI-Generated Summary

Updated February 8, 2026 at 11:10 AM UTC

The bill updates the Federal Food, Drug, and Cosmetic Act to keep two special programs for medical devices active through 2027. It extends the authority that lets the FDA grant a profit‑incentive exemption for humanitarian use devices, and it continues the pediatric device consortia program that supports development of devices for children. These changes affect manufacturers seeking those exemptions and the agencies that oversee them.

Key Provisions

  • Extends the humanitarian device exemption profit‑incentive authority from its 2022 expiration to 2027.
  • Extends the pediatric device consortia program authorization from fiscal years 2018‑2022 to fiscal years 2023‑2027.

Legislative Activity

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1 earlier action
HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 6, 2022

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HouseIntro Referral

Introduced in House

May 6, 2022

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 6, 2022

Bill Text

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Introduced in HouseIssued May 6, 2022

I

117th CONGRESS

2d Session

H. R. 7679

IN THE HOUSE OF REPRESENTATIVES

May 6, 2022

Mrs. Fletcher (for herself and Mr. Bilirakis) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

1.

Reauthorizing the humanitarian device exemption profit incentive

Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 2022 and inserting 2027.

2.

Reauthorizing the pediatric device consortia program

Section 305(e) of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 282 note) is amended by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027.