HR 4511 117th Congress House

FACTS Act

Official title: To amend the Federal Food, Drug, and Cosmetic Act to authorize the use of emergency use authorization data and real world evidence gathered during an emergency… Show full official titleShow less

Official title: To amend the Federal Food, Drug, and Cosmetic Act to authorize the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

Introduced: July 19, 2021 See on congress.gov

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

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Jul 20, 2021

Referred to the Subcommittee on Health.

Jul 19, 2021

Referred to the House Committee on Energy and Commerce.

Jul 19, 2021

Introduced in House

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Latest action July 20, 2021

Referred to the Subcommittee on Health.

Plain-English summary Congressional Research Service

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.

Bill text 1 version