S. 1069: Medical Device Safety Monitoring Act
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S. 1069: Medical Device Safety Monitoring Act
115th Congress · introduced 2017-05-08 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
federal
Follow this bill, step by step
- Where it came from: introduced 2017-05-08 · official record
- Who proposed it: Sen. Casey, Robert P., Jr. [D-PA] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
Medical Device Safety Monitoring Act
Plain summary
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.
Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.
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What does this mean? (plain words)
Official text
Medical Device Safety Monitoring Act
Source: Congressional Research Service summary (Introduced in Senate)
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Sen. Casey, Robert P., Jr. [D-PA] · 2 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Elizabeth Warren (D-MA)
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (1)
- Bill
- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-115s1069.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/115/s>
Record fed-us-cong115-s1069 · catalog fed-us-congress-bills-cong115 · updated 2026-11-15 by psicol fed-bills-cong115