3.0.0 1069 2023-01-11T13:36:29Z 2023-01-11T13:36:29Z Senate S 2017-05-08 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2017-05-08T22:38:37Z FDA Reauthorization Act of 2017 115 934 S 2017-05-11 Placed on Senate Legislative Calendar under General Orders. Calendar No. 76. Related bill CRS FDA Reauthorization Act of 2017 115 2430 HR 2017-08-18 Signed by President. Related bill CRS 2017-05-08 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-05-08 Introduced in Senate IntroReferral 10000 9 Library of Congress C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA N W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. 2017-05-08 True F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2017-05-08 True Health Drug safety, medical device, and laboratory regulation Government information and archives Government studies and investigations Health information and medical records Health technology, devices, supplies Product safety and quality Public contracts and procurement Technology assessment Health 00 2017-05-08 Introduced in Senate 2018-01-17T21:54:44Z Medical Device Safety Monitoring Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to support pilot projects in order to provide timely and reliable information on the safety and effectiveness of marketed medical devices. The projects must: (1) be designed to generate safety and active surveillance data, (2) inform support for safety and active surveillance activities, (3) be coordinated with a system for evaluating medical device technology that operates under a board with representation from consumer groups and device manufacturers, and (4) use electronic health data.

The FDA may determine that a manufacturer's participation in a pilot project satisfies requirements regarding reporting or postmarket surveillance if the project captures adverse event information and the FDA has established procedures to publish safety information from the project.

Not later than January 31, 2021, the FDA must evaluate real world evidence pilot projects, such as the ones supported by this bill, for their ability to inform decision-making and efficiently generate evidence about the safety or effectiveness of medical devices.

]]> Medical Device Safety Monitoring Act Display Title Medical Device Safety Monitoring Act Official Title as Introduced A bill to establish pilot projects in order to provide timely and reliable information on the safety and effectiveness of cleared or approved devices. Introduced in Senate IS Short Titles as Introduced Medical Device Safety Monitoring Act Introduced in Senate 2017-05-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s1069is/xml/BILLS-115s1069is.xml 2017-05-08 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.