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Faster Access to Foreign-Approved Drugs and Medical Devices

New rules aim to streamline access to drugs, biological products, and medical devices already approved for sale in other countries. This means these products could reach the U.S. market faster if they meet specific safety and effectiveness criteria, potentially improving access to vital treatments for citizens.
Key points
Allows faster U.S. market approval for drugs and medical devices already legally sold in selected countries (e.g., United Kingdom).
Requires these products to meet safety and effectiveness criteria and address unmet medical needs in the U.S.
The FDA has 30 days to decide on approval, significantly speeding up the process compared to standard procedures.
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Additional Information
Print number: 117_HR_724
Sponsor: Rep. Roy, Chip [R-TX-21]
Process start date: 2021-02-02