Legis Daily

Increase Access to COVID Testing Act

USA117th CongressS-3516| Senate 
| Updated: 1/18/2022
Ben Sasse

Ben Sasse

Republican Senator

Nebraska

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Increase Access to COVID Testing Act This bill directs the Food and Drug Administration (FDA) to provide upon request emergency use authorization for COVID-19 rapid antigen tests approved for use in the European Union. During the declared COVID-19 public health emergency, the FDA shall grant emergency use authorization to a COVID-19 rapid antigen test upon a proper request by the test's manufacturer if (1) the test is on the European Commission Directorate-General for Health and Food Safety's common list for approved COVID-19 tests, and (2) the request is for the non-laboratory use of the test without a prescription. The bill waives certain requirements for a request for emergency use authorization under this bill, such as a finding from the FDA that the test may be effective in diagnosing COVID-19. If a test authorized under this bill is removed from the EU common list, the FDA must determine within 30 days of such removal whether the emergency use authorization for the test should continue.
View Full Text

Suggested Questions

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

Timeline
Jan 18, 2022
Introduced in Senate
Jan 18, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 18, 2022
    Introduced in Senate


  • January 18, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Cardiovascular and respiratory healthDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careEuropeEuropean UnionInfectious and parasitic diseasesMedical tests and diagnostic methods

Increase Access to COVID Testing Act

USA117th CongressS-3516| Senate 
| Updated: 1/18/2022
Increase Access to COVID Testing Act This bill directs the Food and Drug Administration (FDA) to provide upon request emergency use authorization for COVID-19 rapid antigen tests approved for use in the European Union. During the declared COVID-19 public health emergency, the FDA shall grant emergency use authorization to a COVID-19 rapid antigen test upon a proper request by the test's manufacturer if (1) the test is on the European Commission Directorate-General for Health and Food Safety's common list for approved COVID-19 tests, and (2) the request is for the non-laboratory use of the test without a prescription. The bill waives certain requirements for a request for emergency use authorization under this bill, such as a finding from the FDA that the test may be effective in diagnosing COVID-19. If a test authorized under this bill is removed from the EU common list, the FDA must determine within 30 days of such removal whether the emergency use authorization for the test should continue.
View Full Text

Suggested Questions

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

Timeline
Jan 18, 2022
Introduced in Senate
Jan 18, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 18, 2022
    Introduced in Senate


  • January 18, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Ben Sasse

Ben Sasse

Republican Senator

Nebraska

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Cardiovascular and respiratory healthDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careEuropeEuropean UnionInfectious and parasitic diseasesMedical tests and diagnostic methods