3.0.0 2427 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. 2427.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 2015-05-22T15:10:27Z Referred to 2015-05-19T14:05:45Z 21st Century Cures Act 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 Improving Medical Device Innovation Act 114 2737 S 2016-03-17 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 Advisory bodies Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Product safety and quality Health 00 2015-05-19 Introduced in House 2015-11-16T17:35:17Z This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel.

The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device.

The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.]]> To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. Display Title To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. Introduced in House IH Introduced in House 2015-05-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr2427ih/xml/BILLS-114hr2427ih.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.