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PREVENT Medical Device Shortages Act of 2022

USA117th CongressS-3477| Senate 
| Updated: 1/11/2022
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (1)
Susan M. Collins (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022 This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues. Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues. The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device. Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.
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Timeline
Jan 11, 2022
Introduced in Senate
Jan 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 11, 2022
    Introduced in Senate


  • January 11, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 117-3799: PREVENT Pandemics Act
  • S 117-3834: A bill to strengthen medical device supply chains.

PREVENT Medical Device Shortages Act of 2022

USA117th CongressS-3477| Senate 
| Updated: 1/11/2022
Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022 This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues. Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues. The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device. Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.
View Full Text

Suggested Questions

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

Timeline
Jan 11, 2022
Introduced in Senate
Jan 11, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 11, 2022
    Introduced in Senate


  • January 11, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (1)
Susan M. Collins (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-3799: PREVENT Pandemics Act
  • S 117-3834: A bill to strengthen medical device supply chains.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted