Do I need an FDA U.S. Agent?

You need an FDA U.S. Agent if your facility is outside the United States and must register with FDA because it makes, processes, packs or holds food, medical devices, drugs or cosmetics for the U.S. market. Answer five questions below to see which programs apply. General guidance only, not legal advice.

Rules: 21 CFR 1.225–1.235 · 21 CFR 807.40 · 21 CFR 207.69 · FDA cosmetics registration