3.0.0 3847 2019-11-15T21:15:52Z 2019-11-15T21:15:52Z House H HR 2012-01-31 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MARKEY:H.R. 3847.Congress has the power to enact this legislation pursuantto the following:Clause 3 of section 8 or article I of the Constitution[Page H219]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2012-01-31T17:02:50Z 2012-01-31 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-01-31 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-01-31 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 2012-01-31 True S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2012-01-31 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2012-01-31 True S000480 Rep. Slaughter, Louise McIntosh [D-NY-28] LOUISE SLAUGHTER D NY M. 28 2012-02-29 False Health Administrative remedies 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 2012-01-31 Introduced in House 2012-05-08T21:15:11Z Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws.

Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services (HHS) or determined to be misbranded or adulterated by judicial order.

Permits the FDA to reject a claim of substantial equivalency for a device whose predicate has been corrected or removed from the market by its sponsor.

Requires the Secretary to maintain an up-to-date database for purposes of determining whether devices are eligible for use as a predicate device.

Requires each manufacturer's corrective action or removal of device report to contain the root cause of each defect leading to the corrective action or removal.

Requires a manufacturer's report for devices in the same lineage as devices that have been subject to corrections or removals and requires such report to explain why the subsequent device does not share the flaws of its predecessor device.

Requires the Secretary to conduct a review of all covered devices to identify any such devices with respect to which a predicate device, or any device in the full device lineage, has been corrected or removed from the market pursuant to a Class I or Class II recall.

]]> SOUND Devices Act of 2012 Short Titles as Introduced SOUND Devices Act of 2012 Short Titles as Introduced Safety Of Untested and New Devices Act of 2012 Display Title SOUND Devices Act of 2012 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes. Introduced in House 2012-01-31T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3847ih/xml/BILLS-112hr3847ih.xml 2012-01-31 Referred to the House Committee on Energy and Commerce. 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.