This proposal would let some medicines, biologic treatments, and medical devices that are already allowed in certain other countries be sold in the U.S. through a faster “reciprocal” path when there is a public health or unmet medical need. A company could ask the FDA to rely on those foreign approvals if the product is approved in specific countries named in law or the United Kingdom, has not been pulled for safety or effectiveness, is not already approved here, and is not a banned device. The FDA could still say no if it finds the product is not safe or effective, and it may require follow‑up safety studies after approval. The FDA must decide within 30 days of a request; during that time, labeling would be finalized and devices would be properly classified. If the FDA declines, Congress can pass a joint resolution to let the product move forward through this pathway. The usual FDA fees would apply, and the government would run an outreach effort to encourage eligible products to apply.

Key points

• Who is affected: People needing treatments not yet available in the U.S.; drug, biologic, and device developers; the FDA.
• What changes: Creates a reciprocal approval option using approvals from certain countries or the UK; allows FDA to require post‑approval studies; sets labeling and device classification during review; and permits Congress to reverse an FDA denial via a joint resolution .
• When: The FDA must issue a decision within 30 days after receiving a request.