H.R. 872House115th Congress (2017-2019)In Committee

DEVICE Act of 2017

Sponsored by Ted LieuRep. Ted Lieu (D-CA)
Introduced February 6, 2017

AI-Generated Summary

Updated April 15, 2026 at 12:27 PM UTC

The DEVICE Act amends the Federal Food, Drug, and Cosmetic Act to tighten oversight of medical devices. It requires manufacturers to notify the FDA before changing a device’s design or its reprocessing instructions, and to report certain communications about those changes to health‑care providers abroad. The bill also adds a new category of “rapid assessment tests” for reusable devices and obligates the FDA to set standards for the instructions and validation data that must accompany those tests.

Key Provisions

  • Manufacturers must give written notice to the FDA before making any design change or changing the recommended reprocessing instructions for a device sold in interstate commerce.
  • If a manufacturer (or its affiliate) communicates a design change, reprocessing change, or safety concern to health‑care providers in a foreign country, it must notify the FDA in writing within five calendar days.
  • The definition of a medical device is expanded to include rapid assessment tests that verify proper reprocessing of reusable devices, and “reusable device” is defined as one intended for multiple uses that must be sanitized.
  • The FDA Secretary must create and regularly update a list of rapid assessment test types that require validated instructions for use and validation data; the FDA cannot accept clearance notifications for those tests without the required information.

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

February 10, 2017

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HouseIntro Referral

Introduced in House

February 6, 2017

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

February 6, 2017

HouseCommittee

Referred to the Subcommittee on Health.

February 10, 2017

Floor Debate

17 members

What members said about H.R. 872 on the floor

9 Republicans8 Democrats
Bob Gibbs
Rep. Bob GibbsR-OH-7 · May 24, 2017

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous materials. Mr. Chair, I yield myself as much…

Grace F. Napolitano
Rep. Grace F. NapolitanoD-CA-32 · May 24, 2017

Mr. Chair, I yield myself such time as I may consume. Mr. Chair, I rise in strong opposition to H.R. 953, Reducing the Regulatory Burdens Act. As I have noted before on similar bills in the past, I…

Jared Huffman
Rep. Jared HuffmanD-CA-2 · May 24, 2017

Mr. Chair, I have an amendment at the desk. Mr. Chair, I appreciate the opportunity to offer this amendment and to speak against the underlying bill. Unfortunately, I wasn't serving the House in 2011…

Peter A. DeFazio
Rep. Peter A. DeFazioD-OR-4 · May 24, 2017

I thank the gentlewoman for yielding. Mr. Chairman, this is the fifth time the United States House of Representatives has considered this bill. Now, we have heard a lot of alternative facts today.…

James P. McGovern
Rep. James P. McGovernD-MA-2 · May 24, 2017

Mr. Speaker, I have a motion to recommit at the desk. Mr. Speaker, I am opposed to the bill in its current form. Mr. Speaker, this is the final amendment to the bill, which will not kill the bill or…

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Rodney Davis
Rep. Rodney DavisR-IL-13 · May 24, 2017

Mr. Chair, I yield myself such time as I may consume. Mr. Chair, I rise today also in support of H.R. 953, the Reducing Regulatory Burdens Act of 2017. The House Committee on Agriculture, which I…

Elizabeth H. Esty
Rep. Elizabeth H. EstyD-CT-5 · May 24, 2017

Mr. Chair, I have an amendment at the desk. Mr. Chairman, I rise in support of my amendment to H.R. 953, the Reducing Regulatory Burdens Act of 2017. The underlying bill is overly broad, and not only…

Steve Scalise
Rep. Steve ScaliseR-LA-1 · May 24, 2017

Mr. Chairman, I want to first thank my colleague from Ohio for his leadership on bringing forth this important legislation to actually help us focus more resources on killing mosquitoes, especially…

Kathy Castor
Rep. Kathy CastorD-FL-14 · May 24, 2017

Mr. Chairman, as the co-chair of the bipartisan Congressional Soccer Caucus, along with my co-chairs, Representative Don Bacon, Darin LaHood, and Eric Swalwell, I am pleased to inform the House that…

Jim Costa
Rep. Jim CostaD-CA-16 · May 24, 2017

Mr. Chairman, I rise in strong support of H.R. 953, Reducing Regulatory Burdens Act of 2017. This legislation eliminates the requirement to acquire two permits for the same pesticide application…

Ted S. Yoho
Rep. Ted S. YohoR-FL-3 · May 24, 2017

Mr. Chairman, I thank my colleague for yielding me just a moment to speak on the absolute necessity of passing the Reducing Regulatory Burdens Act. The Sixth Circuit Court blatantly overstepped its…

Collin C. Peterson
Rep. Collin C. PetersonD-MN-7 · May 24, 2017

Mr. Chairman, I rise today to support the Reducing Regulatory Burdens Act of 2017. This bill would restore congressional intent regarding the relationship between FIFRA and the Clean Water Act.…

Rick W. Allen
Rep. Rick W. AllenR-GA-12 · May 24, 2017

Mr. Chairman, I thank the gentleman from Ohio for his work on this important legislation. Today, I rise in support of H.R. 953, the Reducing Regulatory Burdens Act. This legislation will bring…

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Martha McSally
Rep. Martha McSallyR-AZ-2 · May 24, 2017

Mr. Speaker, the man who has served as a father figure to me for the past twenty years has taken a turn for the worse in his battle against cancer and his health is rapidly deteriorating. As such, I…

Don Bacon
Rep. Don BaconR-NE-2 · May 24, 2017

Will the gentlewoman yield? Mr. Chairman, it was an honor to be able to have a bipartisan game out there and have a good time. Soccer keeps children in shape. Thousands and thousands of our kids get…

Garret Graves
Rep. Garret GravesR-LA-6 · May 24, 2017

Mr. Speaker, I was absent from votes today on account of traveling with the Vice President on official business to Louisiana. Had I been present, I would have voted ``nay'' on rollcall No. 279,…

Diane Black
Rep. Diane BlackR-TN-6 · May 24, 2017

Mr. Speaker, I was unavoidably absent from the House chamber for votes Wednesday, May 24. Had I been present, I would have voted ``yea'' on rollcall No. 277, ``yea'' on rollcall No. 278, and ``yea''…

Bill Text

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Introduced in HouseIssued February 6, 2017

I

115th CONGRESS

1st Session

H. R. 872

IN THE HOUSE OF REPRESENTATIVES

February 6, 2017

Mr. Ted Lieu of California (for himself, Ms. Judy Chu of California, Mr. Cummings, Ms. Norton, Ms. Moore, and Ms. Slaughter) 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 enhance medical device communications and ensure device cleanliness.

1.

Short title

This Act may be cited as the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 or the DEVICE Act of 2017.

2.

Reporting requirement for design and reprocessing instruction changes

(a)

Adulteration

Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph (j) the following:

(k)

If it is a device with respect to which the manufacturer is in violation of the reporting requirement in section 510(q) (relating to design and reprocessing changes).

.

(b)

Requirement

Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the following:

(q)

Reporting requirement for device design changes

Before making a change to the design of a device, or the reprocessing instructions of a device, that is marketed in interstate commerce, the manufacturer of the device shall give written notice of the change to the Food and Drug Administration.

.

3.

Reporting requirement for certain communications to foreign health care providers

(a)

Adulteration

Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351), as amended by section 2 of this Act, is further amended by inserting after paragraph (k) the following:

(l)

If it is a device with respect to which the manufacturer is in violation of the reporting requirement in section 510(r) (relating to communications to foreign health care providers).

.

(b)

Requirement

Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by section 2 of this Act, is further amended by adding at the end the following:

(r)

Reporting requirement for certain communications to foreign health care providers

(1)

Requirement

The manufacturer of a device that is marketed in interstate commerce shall give written notice to the Food and Drug Administration of any communication described in paragraph (2) not more than 5 calendar days after making such communication.

(2)

Communication described

A communication is described in this paragraph if the communication—

(A)

is made by the manufacturer of the device or an affiliate of the manufacturer;

(B)

relates to a change to the design of the device, a change to the recommended reprocessing protocols, if any, for the device, or a safety concern about the device; and

(C)

is widely disseminated (including on a voluntary basis) to health care providers in a foreign country.

(3)

Affiliate

In this subsection, the term affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A)

one business entity controls, or has the power to control, the other business entity; or

(B)

a third party controls, or has the power to control, both of the business entities.

.

4.

Rapid assessment tests intended to ensure proper reprocessing

(a)

Inclusion in device definition

Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended—

(1)

in paragraph (h)—

(A)

in subparagraph (2), by striking or at the end;

(B)

in subparagraph (3), by striking and at the end and inserting or; and

(C)

by inserting after subparagraph (3) the following:

(4)

a rapid assessment test intended to ensure the proper reprocessing of a reusable device (as defined in paragraph (ss)), and

; and

(2)

by adding at the end the following:

(ss)

The term reusable device means a device that—

(1)

is intended to be used more than one time; and

(2)

must be sanitized (whether through cleaning, disinfection, or sterilization) to ensure that the device is safe and effective for such intended use.

.

(b)

Instructions for use and validation data

Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by sections 2 and 3 of this Act, is further amended by adding at the end the following:

(s)

Instructions for use and validation data

(1)

Initial list

Not later than 1 year after the date of enactment of this subsection, the Secretary shall by regulation develop and publish a list of types of rapid assessment tests described in section 201(h)(4) for which reports under subsection (k) must include—

(A)

instructions for use that have been validated in a manner specified by the Secretary; and

(B)

validation data, of the types specified by the Secretary.

(2)

Updates

The Secretary shall by regulation periodically update the list required by paragraph (1).

(3)

Enforcement

Beginning on the date of publication of the initial list under paragraph (1), the Secretary shall not accept any notification under subsection (k) for clearance of a type of rapid assessment test that is included on such list unless such notification includes instructions for use and validation data in accordance with paragraph (1).

.