3.0.0 3208 2023-01-11T13:22:05Z 2023-01-11T13:22:05Z House H HR 2011-10-14 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SHIMKUS:H.R. 3208.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to Article 1, Section 8,Clause 3 of the United States Constitution.[Page H6977]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-10-18T13:48:36Z Referred to 2011-10-14T13:02:25Z 2011-10-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-10-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-10-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-10-14 Introduced in House IntroReferral 1000 9 Library of Congress S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 N G000550 Rep. Gingrey, Phil [R-GA-11] Phil Gingrey R GA 11 2011-10-14 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2011-10-14 True L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2011-10-14 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-10-14 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2011-10-14 True B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2011-10-14 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2011-10-14 True B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2011-10-14 True P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2011-10-14 True C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2011-10-14 True L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2011-10-14 True C001048 Rep. Culberson, John Abney [R-TX-7] JOHN CULBERSON R TX ABNEY 7 2011-11-30 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2011-11-30 False A000358 Rep. Akin, W. Todd [R-MO-2] W. AKIN R MO TODD 2 2011-12-16 False M001182 Rep. Mulvaney, Mick [R-SC-5] Mick Mulvaney R SC 5 2012-01-18 False R000592 Rep. Rokita, Todd [R-IN-4] Todd Rokita R IN 4 2012-01-25 False G000565 Rep. Gosar, Paul A. [R-AZ-1] Paul Gosar R AZ A. 1 2012-04-24 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health technology, devices, supplies Health 00 2011-10-14 Introduced in House 2012-02-23T15:16:13Z Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device.

Directs the Secretary to: (1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices, (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner, (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and (4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.

]]> Patients Come First Act of 2011 Display Title Patients Come First Act of 2011 Official Title as Introduced To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. Introduced in House IH Short Titles as Introduced Patients Come First Act of 2011 Introduced in House 2011-10-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3208ih/xml/BILLS-112hr3208ih.xml 2011-10-18 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.