Importing Devices for U.S. Clinical Investigations

Importing a device for a U.S. clinical investigation requires more than arranging transportation. The regulatory basis for the study, the product presented at the border, and the records maintained after release must describe the same device, intended use and investigation.

Confirm the Regulatory Basis Before Shipment

Before shipment, the sponsor should determine whether the investigation proceeds under a Food and Drug Administration-approved Investigational Device Exemption or without an FDA submission based on an Institutional Review Board determination. An IRB is the U.S. term for an ethics committee.

The import file should contain either the active IDE number or written IRB confirmation that no FDA submission is required. Calling the activity a pilot, feasibility study or postmarket investigation does not avoid this analysis.

Labels and Shipment Records Must Tell One Story

The device or its immediate package must carry the required investigational-use caution statement. Labels, packing lists, Customs invoices, protocol records and device specifications should use consistent model, lot or serial, quantity and intended-use information.

Commercial labeling should not substitute for the investigational basis of the shipment.

The Customs Entry Must Reflect Clinical Investigational Use

The Customs entry must reflect clinical investigational use and include the appropriate FDA intended-use category and Affirmation of Compliance, supported by the applicable IDE or nonsignificant-risk documentation.

Product code, value, origin, manufacturer, shipper, FDA importer, consignee and supporting records must also be accurate. Incorrectly entering the shipment as a commercial device, evaluation sample or component can create detention or inconsistencies with the study file.

Assign Importer Roles Before Shipment

The Importer of Record is responsible for the Customs entry and associated financial obligations. The FDA importer is identified in FDA entry data, and the Customs broker transmits the entry.

Many clinical study sites will not accept the Importer of Record role because it creates Customs, financial, recordkeeping and compliance obligations outside their normal function. Assuming that a hospital or investigator will accept the role can delay study activation or the first shipment.

Any commercial Device Initial Importer role should be assessed separately.

Connect Customs Records to Study Accountability

After release, Customs records should connect to study accountability records. Imported quantities, receipt condition, temperature history where applicable, quarantine or release status, lot or serial numbers, site shipments, use, returns and destruction should be traceable and reconcilable.

Establish a Controlled U.S. Operational Interface

MDD Studies can provide the U.S. operational interface instead of leaving importer responsibilities to a study site. MDD Studies can coordinate Importer of Record and FDA-entry functions, broker instructions, controlled receipt, cold-chain handling, site distribution, reconciliation, returns and final disposition.

Where the regulatory pathway or allocation of roles remains uncertain, MDD Options can separately assess the proposed structure before shipment.