FACTS Act

Summary

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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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 19 July 2021

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• Introduced in House (PDF)

  Introduced in House · EN · 19 July 2021

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• Introduced in House

  summary · EN · 19 July 2021

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