Medical Device Safety Monitoring Act
The source supplies the latest action, but no lifecycle stage.
Latest action (8 May 2017): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
What this bill does
S. 1069, the Medical Device Safety Monitoring Act, would amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish, within one year of enactment, one or more voluntary pilot projects with medical device manufacturers to generate timely, reliable safety and surveillance data on cleared or approved devices. These projects would use electronic health data, claims data, and patient survey data, be coordinated with a broader medical device evaluation system involving stakeholders such as consumer groups and manufacturers, and prioritize devices that are widely used, whose failure has serious health consequences, or for which real-world evidence would benefit public health. The bill sets requirements for manufacturer participation, data privacy, contractor qualifications, and reporting to Congress, and includes a sunset date of October 1, 2022. It also requires an independent third-party review by January 31, 2021, evaluating the effectiveness of these real-world-evidence pilot projects.
The bill primarily affects the Food and Drug Administration, device manufacturers who choose to participate, and, indirectly, patients and healthcare providers who could benefit from improved post-market safety monitoring. Participation by manufacturers is voluntary, and privacy protections are specified for any patient data used.
The bill was introduced on May 8, 2017, by Senator Bob Casey with two cosponsors and referred to the Senate Committee on Health, Education, Labor, and Pensions. According to the Congressional Research Service, its provisions were not enacted as a standalone bill but were incorporated into other legislation that was later enacted.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official 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.
Timeline
8 May 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Common questions
- What does S. 1069 do?
- S. 1069, the Medical Device Safety Monitoring Act, would amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish, within one year of enactment, one or more voluntary pilot projects with medical device manufacturers to generate timely, reliable safety and surveillance data on cleared or approved devices. These projects would use electronic health data, claims data, and patient survey data, be coordinated with a broader medical device evaluation system involving stakeholders such as consumer groups and manufacturers, and prioritize devices that are widely used, whose failure has serious health consequences, or for which real-world evidence would benefit public health. The bill sets requirements for manufacturer participation, data privacy, contractor qualifications, and reporting to Congress, and includes a sunset date of October 1, 2022. It also requires an independent third-party review by January 31, 2021, evaluating the effectiveness of these real-world-evidence pilot projects. The bill primarily affects the Food and Drug Administration, device manufacturers who choose to participate, and, indirectly, patients and healthcare providers who could benefit from improved post-market safety monitoring. Participation by manufacturers is voluntary, and privacy protections are specified for any patient data used. The bill was introduced on May 8, 2017, by Senator Bob Casey with two cosponsors and referred to the Senate Committee on Health, Education, Labor, and Pensions. According to the Congressional Research Service, its provisions were not enacted as a standalone bill but were incorporated into other legislation that was later enacted.
- Has S. 1069 become law?
- The source does not supply a confirmed lifecycle stage for S. 1069. Check the latest action and official source below.
- Who sponsored S. 1069?
- S. 1069 was sponsored by Sen. Casey, Robert P., Jr. [D-PA] (D-PA), with 2 cosponsors.
- What's the latest action on S. 1069?
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (8 May 2017).
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