Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

This bill would allow faster approval in the U.S. for certain drugs, biologics, and medical devices already approved in specific countries (like Canada or EU nations). Manufacturers could request "reciprocal marketing approval" if the product is legally marketed abroad, meets safety standards, and addresses a U.S. public health need, bypassing the full FDA review process. The FDA must decide within 30 days, and can deny approval for safety concerns or require post-market studies. This directly affects drug/device companies seeking to bring foreign-approved treatments to U.S. patients more quickly.