US Congress Senate Bill 1069 (Prior Session Legislation)

---

Spectrum: Partisan Bill (Democrat 3-0)
Status: Introduced on May 8 2017 - 25% progression, died in committee
Action: 2017-05-08 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

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

Sen. Robert Casey [D-PA]

Sen. Elizabeth Warren [D-MA]

Sen. Al Franken [D-MN]

Date	Chamber	Action
2017-05-08	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

SB934 (Related) 2017-05-11 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 76.
HB2430 (Related) 2017-08-18 - Became Public Law No: 115-52. (TXT | PDF)

Type	Source
Summary	https://www.congress.gov/bill/115th-congress/senate-bill/1069/all-info
Text	https://www.congress.gov/115/bills/s1069/BILLS-115s1069is.pdf