Service
Import and customs
Investigational device shipments and entry documentation for a study in the United States.
What this covers
An investigational device made outside the United States has to reach the study site on time, labeled correctly, and cleared at entry without a hold. Each of those steps is routine when it is planned and expensive when it is not.
Labeling
Investigational devices must carry the statement required by 21 CFR 812.5: "CAUTION. Investigational device. Limited by Federal (or United States) law to investigational use." We check the label, the package insert, and the shipping documents against the regulation and against the IDE as approved.
Entry documentation
FDA reviews regulated products at the port. Your customs broker files the entry, and the entry has to carry the right product code, the IDE number, and the affirmations that tell FDA why the shipment is admissible. We prepare that package, brief the broker, and answer FDA's questions if the shipment is flagged.
Accountability
As sponsor you must account for every investigational device from shipment to use or return. We set up the log and the process with the sites so the record is complete when FDA asks for it.
When you need it
Before the first investigational shipment leaves the factory. The labeling and the entry documentation are checked against the IDE as approved, so the work usually begins the week the approval letter arrives and is finished before the first site is initiated.
What you receive
- Shipment planQuantities, timing, sites, and the documents each shipment needs.
- Labeling checkEvery label and insert reviewed against 21 CFR 812.5 and the approved IDE.
- Entry documentation packagePrepared for your broker, with the data elements FDA requires complete.
- Device accountability logTemplate and process agreed with each site.
What we need from you
- IDE approval letterAnd the device description as approved.
- Quantities and ship-to sitesWith the dates the sites need them.
- Broker detailsOr we can suggest brokers experienced with FDA-regulated entries.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.