3.0.0 2118 2023-01-11T13:35:58Z 2023-01-11T13:35:58Z House HR 2017-04-25 115 [Congressional Record Volume 163, Number 70 (Tuesday, April 25, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. COSTELLO of Pennsylvania:H.R. 2118.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the United States Constitution[Page H2847]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2017-04-28T15:13:15Z Referred to 2017-04-25T16:01:00Z 2017-04-28 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-04-25 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-04-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-04-25 Introduced in House IntroReferral 1000 9 Library of Congress C001106 Rep. Costello, Ryan A. [R-PA-6] Ryan Costello R PA A. 6 N P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2017-04-25 True M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 2017-05-11 False B001296 Rep. Boyle, Brendan F. [D-PA-13] Brendan Boyle D PA F. 13 2017-07-26 False Health Administrative law and regulatory procedures Business records Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies Licensing and registrations Health 00 2017-04-25 Introduced in House 2018-01-17T19:29:08Z Medical Device Servicing Safety and Accountability Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require establishments servicing medical devices to register with the Food and Drug Administration (FDA). Such establishments must maintain records and make reports as the FDA requires to ensure the safety and effectiveness of serviced devices.

The bill exempts certain medical facilities, including physician's offices, that service medical devices in accordance with state and local laws.]]> Medical Device Servicing Safety and Accountability Act Display Title Medical Device Servicing Safety and Accountability Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to require the registration of establishments that service devices, and for other purposes. Introduced in House IH Short Titles as Introduced Medical Device Servicing Safety and Accountability Act Introduced in House 2017-04-25T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr2118ih/xml/BILLS-115hr2118ih.xml 2017-04-28 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.