International Sponsor Program
U.S. Agent, official correspondent, IDE Sponsor of Record, and FDA submission support for Israeli device manufacturers entering the U.S. market.
Israel's Ministry of Health regulates medical devices domestically through its AMAR (medical device registration) process. Israeli device companies — particularly early-stage and venture-backed developers — commonly pursue FDA clearance before or in parallel with CE marking, which means the U.S. pathway is frequently the first regulatory track a device goes through, not a later addition to an existing European approval.
A common pattern for Israeli medical technology is first-in-human clinical experience run outside the U.S., followed by a U.S. IDE application to bring the device into a U.S. clinical study. Early Feasibility Study (EFS) is frequently the right entry point here, letting the device and protocol be refined with a small U.S. cohort informed by the earlier non-U.S. experience rather than committing straight to a full pivotal trial.
An Israeli company without a U.S. entity needs a U.S. Sponsor of Record under 21 CFR Part 812 to run a U.S. IDE study, and a U.S. Agent under 21 CFR 807.40 once the device moves toward U.S. commercial distribution. ADB provides both roles under one team, so the clinical study and the eventual commercial registration are handled by the same accountable practice director rather than separate, disconnected vendors.
Israel Standard Time runs roughly 7 hours ahead of U.S. Eastern Time, which puts an Israeli team's afternoon into a U.S. Eastern morning — a workable window for scheduled calls, with written correspondence through the client portal covering the rest of the day.
Israeli manufacturers most often bring ADB cardiovascular and lead-management devices, digital health and AI-enabled software, and surgical devices — these are areas ADB has supported or is equipped to support, not an exhaustive or exclusive list.
Common Questions
Many Israeli device companies are venture-backed and the U.S. market, plus FDA’s Breakthrough Device and EFS pathways for novel technology, is frequently the priority commercial and regulatory target — so the U.S. pathway is often pursued first or in parallel with CE marking rather than afterward.
Yes — this is a common pattern. FDA will evaluate the non-U.S. first-in-human data as part of the U.S. IDE application, assessing whether the study population, device version, and follow-up protocol are comparable to what’s proposed for the U.S. study.
No — the U.S. Sponsor of Record is itself the U.S.-based entity that takes on the IDE sponsor obligations under 21 CFR Part 812 on the Israeli company’s behalf, so the Israeli company does not need to establish its own U.S. entity to run the study.
AMAR is Israel’s Ministry of Health medical device registration process. It can inform the U.S. regulatory strategy through shared clinical and technical data, but it does not substitute for FDA’s own independent review and clearance decision.
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