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HR 2424 114th Congress House

To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

Introduced: May 19, 2015 See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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Government employee pay, benefits, personnel managementGovernment studies and investigationsHealth technology, devices, suppliesProduct safety and quality
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 22, 2015
Referred to the Subcommittee on Health.
May 19, 2015
Referred to the House Committee on Energy and Commerce.
May 19, 2015
Introduced in House
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 Latest action May 22, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process.

When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.
 Related & companion bills 1
  • HR 6 Related bill 21st Century Cures Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 2424: To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.. 114th Congress. Open America. https://openamerica.io/bill/114-HR-2424/
MLA
"H.R. 2424: To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-2424/.
Bluebook (legal)
H.R. 2424, 114th Cong. (2026), https://openamerica.io/bill/114-HR-2424/.
Markdown link
[H.R. 2424: To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.](https://openamerica.io/bill/114-HR-2424/)
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