3.0.0 1995 2020-02-10T17:02:30Z 2020-02-10T17:02:30Z Senate S S 2011-12-14 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-12-14T23:17:17Z Medical Device Patient Safety Act 112 5866 HR 2012-06-01 Referred to the Subcommittee on Health. Identical bill CRS 2011-12-14 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-12-14 Introduced in Senate IntroReferral 10000 9 Library of Congress G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. N K000305 Sen. Kohl, Herb [D-WI] HERBERT KOHL D WI H. 2011-12-14 True B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2011-12-14 True Health Business records Drug safety, medical device, and laboratory regulation Government information and archives Health technology, devices, supplies Health 00 2011-12-14 Introduced in Senate 2012-05-07T15:55:09Z Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls.

Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall.

Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action.

Requires the Secretary to document and publish specified information concerning termination of a recall.

Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.

]]> Medical Device Patient Safety Act Short Titles as Introduced Medical Device Patient Safety Act Display Title Medical Device Patient Safety Act Official Title as Introduced A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. Introduced in Senate 2011-12-14T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s1995is/xml/BILLS-112s1995is.xml 2011-12-14 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.