3.0.0 2424 2023-01-11T13:31:21Z 2023-01-11T13:31:21Z House HR 2015-05-19 114 [Congressional Record Volume 161, Number 77 (Tuesday, May 19, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SHIMKUS:H.R. 2424.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3: To regulate Commerce withforeign Nations, and among the several States, and with theIndian Tribes.[Page H3389]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-05-22T15:09:47Z Referred to 2015-05-19T14:05:35Z 114 6 HR 2015-07-13 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2015-05-22 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-05-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-05-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-05-19 Introduced in House IntroReferral 1000 9 Library of Congress S000364 Rep. Shimkus, John [R-IL-15] JOHN SHIMKUS R IL M. 15 N 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 employee pay, benefits, personnel management Government studies and investigations Health technology, devices, supplies Product safety and quality Health

00 2015-05-19 Introduced in House 2015-11-17T12:45:14Z This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process.

When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.]]>

Display Title Official Title as Introduced Introduced in House IH Introduced in House 2015-05-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2424ih/xml/BILLS-114hr2424ih.xml 2015-05-22 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.