3.0.0 3205 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. PAULSEN:H.R. 3205.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8.[Page H6977]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-10-18T13:48:20Z Referred to 2011-10-14T13:00:52Z 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 P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 N A000362 Rep. Altmire, Jason [D-PA-4] Jason Altmire D PA 4 2011-10-14 True K000378 Rep. Kinzinger, Adam [R-IL-11] Adam Kinzinger R IL 11 2011-10-14 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2011-10-14 True C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2011-10-14 True S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 2011-10-14 True M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2011-10-14 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-10-14 True L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2011-10-14 True K000363 Rep. Kline, John [R-MN-2] John Kline R MN 2 2011-10-14 True B001256 Rep. Bachmann, Michele [R-MN-6] Michele Bachmann R MN 6 2011-10-14 True C001086 Rep. Cravaack, Chip [R-MN-8] Chip Cravaack R MN 8 2011-10-14 True B001228 Rep. Bono Mack, Mary [R-CA-45] MARY BONO MACK R CA 45 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 2011-10-25 False C001048 Rep. Culberson, John Abney [R-TX-7] JOHN CULBERSON R TX ABNEY 7 2011-12-02 False R000592 Rep. Rokita, Todd [R-IN-4] Todd Rokita R IN 4 2012-01-23 False Health Administrative remedies 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 2012-02-14T22:50:39Z FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities.

Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days.

Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices.

Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days.

Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons.

Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation.

Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.

]]> FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 Display Title FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to persons who, with respect to devices, are accredited to perform certain reviews or inspections. Introduced in House IH Short Titles as Introduced FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 Introduced in House 2011-10-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3205ih/xml/BILLS-112hr3205ih.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.