H.R. 4511 · 117th Congress
FACTS Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BurgessSponsor2 cosponsors · 1 D, 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
FDA Advancing Collection of Transformative Science Act or the FACTS Act
What it does: CRS summary · Introduced in House · Jul 19, 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: FACTS Act
Also known as: FDA Advancing Collection of Transformative Science Act
Latest action (Jul 20, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jul 19, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.