3.0.0 7646 2022-12-29T23:48:33Z 2022-12-29T23:48:33Z House HR 2022-05-03 117 [Congressional Record Volume 168, Number 73 (Tuesday, May 3, 2022)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GUTHRIE:H.R. 7646.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the United States Constitution.[Page H4714]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2022-05-03T14:02:25Z A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices. 117 4349 S 2022-06-06 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2022-05-03 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2022-05-03 Introduced in House IntroReferral Intro-H 9 Library of Congress 2022-05-03 Introduced in House IntroReferral 1000 9 Library of Congress G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 N M001196 Rep. Moulton, Seth [D-MA-6] Seth Moulton D MA 6 2022-05-03 True Health Health 00 2022-05-03 Introduced in House 2022-10-18T14:50:39Z Emerging Signals Modernization Act of 2022

This bill establishes certain requirements relating to the Food and Drug Administration's (FDA's) public notices on the potential new risks of approved medical devices (i.e., emerging signals), including with respect to the standards of evidence needed for such notices. The FDA must update its current guidance on emerging signals to align with the bill's requirements.

]]> Emerging Signals Modernization Act of 2022 Display Title Emerging Signals Modernization Act of 2022 Short Title(s) as Introduced Emerging Signals Modernization Act of 2022 Introduced in House IH Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to notify the public about an emerging signal concerning a medical device in order to reduce or limit the number of patients exposed to a potential risk identified based on such emerging signal, and for other purposes. Introduced in House IH Introduced in House 2022-05-03T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr7646ih/xml/BILLS-117hr7646ih.xml 2022-05-03 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.