International manufacturers can run FDA IDE trials, but must meet U.S. requirements. Key steps include appointing a U.S. sponsor or agent, ensuring compliant device import, addressing cultural/regulatory differences, and leveraging OUS data effectively.
The U.S. is a key market for medical devices, and many international manufacturers need to conduct FDA-regulated trials to support approval. While the IDE regulations apply equally to U.S. and foreign companies, there are special considerations for international sponsors:
FDA regulations mandate that the sponsor of an IDE must be located in the United States. If you are a device company based outside the U.S., you cannot directly sponsor an IDE from abroad. There are a couple of ways to meet this requirement:
Shipping your unapproved device into the U.S. for use in a trial is permissible under an IDE, but it must be done under the IDE’s provisions. Devices should be labeled “Investigational Use Only” and can only be sent to investigators in the study. U.S. Customs will typically look for an IDE number or documentation if there’s any question. Having the IDE approval letter handy can smooth importation. Fun fact: If you are sending devices just for testing in laboratory settings (no human use), that might not require an IDE – but for clinical use, IDE is needed.
Some international companies may have already done a clinical study in another country and wonder if that data can support FDA approval (perhaps avoiding another U.S. trial). FDA can accept foreign clinical data in support of a marketing application if the data are valid and GCP-compliant, but often FDA still requires some U.S. data for familiarity with U.S. population or medical practice differences. Specifically, for an IDE, if a study is conducted entirely outside the U.S., no IDE is required for that foreign study (IDE regulations govern investigations in the U.S.). However, when you later submit those data to FDA (e.g., in a PMA or 510(k)), FDA will evaluate whether the study was conducted under GCP and whether the data are applicable to the U.S. population. FDA’s regulation 21 CFR 812.28 (Acceptance of Foreign Data) outlines criteria like having FDA’s input on the protocol and ensuring the data’s quality. If you plan eventually to use foreign data, it can be wise to discuss with FDA in a Pre-Sub to ensure they will find it acceptable.
If you’ve done a feasibility trial in, say, Europe, and now need a pivotal trial in the U.S., you will likely still need an IDE for the U.S. portion. Leverage your OUS data as prior investigations in the IDE application. The good news is those data can strengthen your IDE submission by demonstrating a prior safety experience. But remember to include even foreign adverse events in your IDE risk analysis and investigator brochure.
International sponsors should be prepared for some differences in U.S. trial conduct:
Many foreign sponsors hire U.S.-based contract research organizations (CROs) or consultants to help manage the IDE process and trial execution. This can be extremely helpful for navigating FDA interactions and local trial logistics. A CRO can serve as the “U.S. sponsor” if properly structured, or simply support your U.S. subsidiary in meeting all obligations.
If you need to send study samples back to your home country for analysis (e.g., pathology or core lab work), ensure the IDE covers that or at least doesn’t prohibit it. Typically it’s fine, but consider any export controls. Unapproved devices can be exported from the U.S. for use in foreign trials under certain conditions (section 802 of FD&C Act), but since here the use is in the U.S., export might only pertain to returning unused devices or moving samples.
Even though you’re foreign-based, once you engage in a U.S. IDE, you are under FDA’s compliance requirements. FDA can audit the sponsor (even if overseas) – usually they would audit the U.S. agent or U.S. operations. They can also inspect manufacturing facilities abroad if needed for the investigational device. Be prepared to comply with FDA’s quality system expectations for investigational devices (design controls, etc., which you should be doing anyway). If language barriers exist in documentation, have translations ready.
In summary, international device companies can absolutely conduct FDA IDE trials, but they must “play by the U.S. rules,” which includes having a U.S.-based sponsor representative and adhering to all FDA and human subject protection regulations. Early planning on corporate structure and engaging U.S. regulatory experts will pay off. Being aware of these requirements prevents delays – for example, not realizing you needed a U.S. sponsor until the last minute could postpone your IDE submission. Plan ahead, and FDA will treat you the same as any domestic sponsor in the IDE review, focusing on the science and safety of your trial.
