Medical Device Safety Monitoring Act
Latest action · May 8, 2017 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMay 8, 2017
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors 2
Members who signed on, in the order they did. All signed on May 8, 2017.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MN | Al Franken | Original | May 8, 2017 |
| D-MA | Elizabeth Warren | Original | May 8, 2017 |
Actions 2
Everything that happened, newest first.
- May 8, 2017Introduced in Senate
- May 8, 2017Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 934 | FDA Reauthorization Act of 2017 | Related bill | May 11, 2017 |
| HR 2430 | FDA Reauthorization Act of 2017 | Related bill | Aug 18, 2017 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- May 8, 2017Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.