3.0.0 2915 2022-11-01T05:47:40Z 2022-11-01T05:47:40Z House HR 2019-05-22 116 [Congressional Record Volume 165, Number 86 (Wednesday, May 22, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. FITZPATRICK:H.R. 2915.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3[Page H4120]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-05-23T17:44:33Z Referred to 2019-05-22T14:04:15Z 2019-05-23 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-05-22 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-05-22 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-05-22 Introduced in House IntroReferral 1000 9 Library of Congress F000466 Rep. Fitzpatrick, Brian K. [R-PA-1] Brian Fitzpatrick R PA K. 1 N D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 2019-05-22 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2019-05-22 True S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2019-05-22 True Health Drug safety, medical device, and laboratory regulation Government information and archives Health care quality Health information and medical records Health personnel Health technology, devices, supplies Product safety and quality Health 00 2019-05-22 Introduced in House 2021-09-12T19:39:03Z Medical Device Guardians Act

This bill requires physicians to report significant adverse experiences caused by medical devices to the Food and Drug Administration (FDA).

The FDA must establish an electronic reporting system to facilitate compliance with this bill and must publish the reports online.

]]> Medical Device Guardians Act Display Title Medical Device Guardians Act 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 Title(s) as Introduced Medical Device Guardians Act Introduced in House IH Introduced in House 2019-05-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr2915ih/xml/BILLS-116hr2915ih.xml 2019-05-23 Referred to the Subcommittee on Health. 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.