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FACTS Act

USA117th CongressHR-4511| House 
| Updated: 7/20/2021
Michael C. Burgess

Michael C. Burgess

Republican Representative

Texas

Cosponsors (2)
Angie Craig (Democratic)Earl L. "Buddy" Carter (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
FDA Advancing Collection of Transformative Science Act or the FACTS Act This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations or procedures, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.
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Timeline
Jul 19, 2021
Introduced in House
Jul 19, 2021
Referred to the House Committee on Energy and Commerce.
Jul 20, 2021
Referred to the Subcommittee on Health.
  • July 19, 2021
    Introduced in House


  • July 19, 2021
    Referred to the House Committee on Energy and Commerce.


  • July 20, 2021
    Referred to the Subcommittee on Health.

Health

Drug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesLicensing and registrations

FACTS Act

USA117th CongressHR-4511| House 
| Updated: 7/20/2021
FDA Advancing Collection of Transformative Science Act or the FACTS Act This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations or procedures, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.
View Full Text

Suggested Questions

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

Timeline
Jul 19, 2021
Introduced in House
Jul 19, 2021
Referred to the House Committee on Energy and Commerce.
Jul 20, 2021
Referred to the Subcommittee on Health.
  • July 19, 2021
    Introduced in House


  • July 19, 2021
    Referred to the House Committee on Energy and Commerce.


  • July 20, 2021
    Referred to the Subcommittee on Health.
Michael C. Burgess

Michael C. Burgess

Republican Representative

Texas

Cosponsors (2)
Angie Craig (Democratic)Earl L. "Buddy" Carter (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesLicensing and registrations