Legis Daily

A bill to establish pilot projects in order to provide timely and reliable information on the safety and effectiveness of cleared or approved devices.

USA115th CongressS-1069| Senate 
| Updated: 5/8/2017
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (2)
Elizabeth Warren (Democratic)Al Franken (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 8, 2017
Introduced in Senate
May 8, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • May 8, 2017
    Introduced in Senate


  • May 8, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 115-2430: FDA Reauthorization Act of 2017
  • S 115-934: FDA Reauthorization Act of 2017
Drug safety, medical device, and laboratory regulationGovernment information and archivesGovernment studies and investigationsHealth information and medical recordsHealth technology, devices, suppliesProduct safety and qualityPublic contracts and procurementTechnology assessment

A bill to establish pilot projects in order to provide timely and reliable information on the safety and effectiveness of cleared or approved devices.

USA115th CongressS-1069| Senate 
| Updated: 5/8/2017
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 8, 2017
Introduced in Senate
May 8, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • May 8, 2017
    Introduced in Senate


  • May 8, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (2)
Elizabeth Warren (Democratic)Al Franken (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 115-2430: FDA Reauthorization Act of 2017
  • S 115-934: FDA Reauthorization Act of 2017
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationGovernment information and archivesGovernment studies and investigationsHealth information and medical recordsHealth technology, devices, suppliesProduct safety and qualityPublic contracts and procurementTechnology assessment