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   &lt;pre&gt;[Congressional Record Volume 167, Number 22 (Friday, February 5, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Mr. LIEU:H.R. 887.Congress has the power to enact this legislation pursuantto the following:Pursuant to Article 1, Section 8.[Page H470]&lt;/pre&gt;
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     &lt;p&gt;&lt;b&gt; Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 &lt;/b&gt;&lt;/p&gt; &lt;p&gt;This bill addresses design changes and reprocessing of medical devices. &lt;/p&gt; &lt;p&gt;Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) &lt;/p&gt; &lt;p&gt;A device may not be sold if the manufacturer violates these notification requirements.&lt;/p&gt;
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2021-02-08
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-02-05
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
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2021-02-05
9
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Introduced in House
IntroReferral
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2021-02-05
9
Library of Congress
Introduced in House
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2021-02-05T14:04:20Z
Referred to
House
Energy and Commerce Committee
2021-02-08T21:06:13Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
C001080
27
Judy
Rep. Chu, Judy [D-CA-27]
Chu
D
2021-02-05
CA
N000147
0
ELEANOR
Del. Norton, Eleanor Holmes [D-DC-At Large]
NORTON
HOLMES
D
2021-02-05
DC
Congressional Research Service, Library of Congress
This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
2021-02-05
2021-02-08
Referred to the Subcommittee on Health.
House
Health
L000582
33
Ted
Rep. Lieu, Ted [D-CA-33]
N
Lieu
D
CA
Business records Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies
2021-02-05
Introduced in House
 <p><b> Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 </b></p> <p>This bill addresses design changes and reprocessing of medical devices. </p> <p>Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) </p> <p>A device may not be sold if the manufacturer violates these notification requirements.</p>
2021-03-22T19:31:42Z
00
2021-02-05T05:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr887ih/xml/BILLS-117hr887ih.xml
DEVICE Act of 2021
DEVICE Act of 2021
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Introduced in House
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Introduced in House
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Short Title(s) as Introduced
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2023-03-08T20:12:44Z
2023-03-08T20:12:44Z
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2021-02-08
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Referred to the Subcommittee on Health.
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2021-02-05
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2021-02-05
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2021-02-05
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Business records Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies
2021-02-05
Introduced in House
 <p><b> Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 </b></p> <p>This bill addresses design changes and reprocessing of medical devices. </p> <p>Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) </p> <p>A device may not be sold if the manufacturer violates these notification requirements.</p>
2021-03-22T19:31:42Z
00
DEVICE Act of 2021
DEVICE Act of 2021
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.
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IH
Introduced in House
DEVICE Act of 2021
Short Title(s) as Introduced
IH
Introduced in House
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021
Short Title(s) as Introduced
2021-02-08
Referred to the Subcommittee on Health.