3.0.0 3975 2019-11-15T21:18:13Z 2019-11-15T21:18:13Z House H HR 2012-02-08 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ROGERS of Michigan:H.R. 3975.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 1: ``The Congress shall havePower to regulate Commerce with foreign Nations, and amongthe several States, and with the Indian tribes''[Page H640]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-02-10T15:12:59Z Referred to 2012-02-08T14:50:51Z 2012-02-10 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-02-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-02-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-02-08 Introduced in House IntroReferral 1000 9 Library of Congress R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 N M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 2012-02-08 True Health Administrative law and regulatory procedures Child health Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health care coverage and access Health information and medical records Health programs administration and funding Health technology, devices, supplies Health 00 2012-02-08 Introduced in House 2012-06-01T21:33:49Z Amends the Pediatric Medical Device Safety and Improvement Act to authorize appropriations through FY2017 for grants for demonstration projects to promote pediatric device development.

Amends the Federal Food, Drug, and Cosmetic Act to allow an exception to the prohibition against selling a device that is designed to treat or diagnose a disease or condition which affects fewer than 4,000 individuals in the United States and that is exempt from the effectiveness requirements of such Act for an amount that exceeds the costs of research and development, fabrication, and distribution of the device where the request for such exemption is submitted on or before October 1, 2017 (currently, October 1, 2012).

Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) entitled "Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure" to take effect on January 1, 2013, unless such Commissioner issues the final rule before such date.

]]> To amend title V of the Federal Food, Drug, and Cosmetic Act to extend the provisions of the Pediatric Medical Device Safety and Improvement Act. Official Title as Introduced To amend title V of the Federal Food, Drug, and Cosmetic Act to extend the provisions of the Pediatric Medical Device Safety and Improvement Act. Display Title To amend title V of the Federal Food, Drug, and Cosmetic Act to extend the provisions of the Pediatric Medical Device Safety and Improvement Act. Introduced in House 2012-02-08T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3975ih/xml/BILLS-112hr3975ih.xml 2012-02-10 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.