3.0.0 4965 2023-01-11T13:31:37Z 2023-01-11T13:31:37Z House HR 2016-04-15 114 [Congressional Record Volume 162, Number 58 (Friday, April 15, 2016)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. TED LIEU of California:H.R. 4965.Congress has the power to enact this legislation pursuantto the following:Pursuant to Article 1, Section 8.[Page H1765]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2016-04-22T18:23:35Z Referred to 2016-04-15T13:01:00Z 2016-04-22 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2016-04-15 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2016-04-15 Introduced in House IntroReferral Intro-H 9 Library of Congress 2016-04-15 Introduced in House IntroReferral 1000 9 Library of Congress L000582 Rep. Lieu, Ted [D-CA-33] Ted Lieu D CA 33 N C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2016-04-21 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2016-05-06 False M001160 Rep. Moore, Gwen [D-WI-4] Gwen Moore D WI 4 2016-05-06 False C001080 Rep. Chu, Judy [D-CA-27] Judy Chu D CA 27 2016-05-11 False H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2016-05-13 False S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 2016-06-03 False Health Business records Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies Health 00 2016-04-15 Introduced in House 2017-02-06T19:20:58Z Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring a manufacturer of a medical device to give the Food and Drug Administration (FDA) premarket notification of changes to the design or reprocessing instructions of its device.

Medical device manufacturers must also notify the FDA within five days of widely disseminating to health care providers in a foreign country communications relating to a change to the recommended reprocessing protocols, if any, for their device, or a safety concern about the device.

The bill bans the devices if the manufacturers violate the notification requirements concerning those design or reprocessing changes or communications to foreign health care providers.

The FDA must publish a list of the types of rapid assessment tests of reusable devices for which premarket notification must include proposed labeling, including validated instructions regarding sanitizing reusable devices.

]]> Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016 Display Title Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness. Introduced in House IH Short Titles as Introduced Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016 Introduced in House 2016-04-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr4965ih/xml/BILLS-114hr4965ih.xml 2016-04-22 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.