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HR 4965 114th Congress House

Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016

Official title: To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.

Introduced: April 15, 2016 Introduced by: Lieu, Ted Democratic · California See on congress.gov
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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
Apr 22, 2016
Referred to the Subcommittee on Health.
Apr 15, 2016
Referred to the House Committee on Energy and Commerce.
Apr 15, 2016
Introduced in House
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 Latest action April 22, 2016

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring a manufacturer of a medical device to give the Food and Drug Administration (FDA) premarket notification of changes to the design or reprocessing instructions of its device.

Medical device manufacturers must also notify the FDA within five days of widely disseminating to health care providers in a foreign country communications relating to a change to the recommended reprocessing protocols, if any, for their device, or a safety concern about the device.

The bill bans the devices if the manufacturers violate the notification requirements concerning those design or reprocessing changes or communications to foreign health care providers.

The FDA must publish a list of the types of rapid assessment tests of reusable devices for which premarket notification must include proposed labeling, including validated instructions regarding sanitizing reusable devices.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 3
All 3 Democratic 3
D
Chu, Judy
California · May 11, 2016
 D
Moore, Gwen
Wisconsin · May 6, 2016
 D
Norton, Eleanor Holmes
District of Columbia · May 6, 2016
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4965: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016. 114th Congress. Open America. https://openamerica.io/bill/114-HR-4965/
MLA
"H.R. 4965: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-4965/.
Bluebook (legal)
H.R. 4965, 114th Cong. (2026), https://openamerica.io/bill/114-HR-4965/.
Markdown link
[H.R. 4965: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016](https://openamerica.io/bill/114-HR-4965/)
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