Medical Device Guardians Act of 2016

3.0.0 5404 2023-01-11T13:32:49Z 2023-01-11T13:32:49Z House HR 2016-06-08 114 [Congressional Record Volume 162, Number 90 (Wednesday, June 8, 2016)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. FITZPATRICK:H.R. 5404.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3[Page H3564]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2016-06-08T14:00:34Z 2016-06-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2016-06-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2016-06-08 Introduced in House IntroReferral 1000 9 Library of Congress F000451 Rep. Fitzpatrick, Michael G. [R-PA-8] Michael Fitzpatrick R PA G. 8 N S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 2016-06-08 True Z000018 Rep. Zinke, Ryan K. [R-MT-At Large] Ryan Zinke R MT K. 0 2016-06-08 True L000554 Rep. LoBiondo, Frank A. [R-NJ-2] FRANK LOBIONDO R NJ A. 2 2016-06-14 False H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2016-06-22 False L000562 Rep. Lynch, Stephen F. [D-MA-8] Stephen Lynch D MA F. 8 2016-06-22 False S000522 Rep. Smith, Christopher H. [R-NJ-4] CHRISTOPHER SMITH R NJ H. 4 2016-07-14 False Health Drug safety, medical device, and laboratory regulation Health care quality Health information and medical records Health personnel Health technology, devices, supplies Product safety and quality Health

00 2016-06-08 Introduced in House 2017-01-26T14:56:19Z Medical Device Guardians Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring physicians to report to the Food and Drug Administration about significant adverse experiences caused by medical devices.

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Medical Device Guardians Act of 2016 Display Title Medical Device Guardians Act of 2016 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to require physicians and physician's offices to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes. Introduced in House IH Short Titles as Introduced Medical Device Guardians Act of 2016 Introduced in House 2016-06-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr5404ih/xml/BILLS-114hr5404ih.xml 2016-06-08 Referred to the House Committee on Energy and Commerce. 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. 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.