Hello Anon,
In general terms, importation of goods into the United States (as you reference being a US-based company and intended for IDE) depend on the Customs and Border Protection review of the component, part, or product. If the product appears to be a medical device, then they will check the US FDA Medical Device Listing to see if registered, otherwise the product might get detained. When importing components which could be perceived or viewed as a medical device, ensure the labelling is clear and description in the Bill of Lading/Invoice. You can find further information here: https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us#process and further information on the CBP site for importation of goods. In practice, we used wording such as "Not for Human Use" or "Part of Investigational Device Component" of labelling direct on the part/component and then further description in the Bill of Lading/Invoice. Also make sure your contact information is available such as email or phone. I have seen many products get detained and sent back because CBP can not get hold of the right person.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Aug-2023 13:11
From: Anonymous Member
Subject: Looking for US Importation advice on Medical device component
This message was posted by a user wishing to remain anonymous
We are a US-based company seeking to import medical device components that will undergo further labeling by us and be distributed as integral parts of our system.
These components are fully finished and sterilized. They hold a significant role within the system, intended for IDE.
Considering that these components are not standalone finished medical devices and are not yet planned for commercialization, we are inquiring whether there are specific importation requirements to be aware of, such as labeling obligations or any other relevant stipulations.
Your insights or recommendations, including references to a knowledgeable US importer experienced in medical device importation, would be greatly appreciated.