Who needs to have a FDA-registered Initial Importer?

A foreign manufacturer who has FDA Establishment Registration with a listed device must have a FDA-registered Initial Importer. MDPPS will contract with anyone in the supply chain to be Initial Importer, but the Initial Importer must have the contact info with the manufacturer to reference the device listing number.

Which companies in the supply chain need FDA Establishment?

See https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee for the complete list. Manufacturers and Initial Importers need FDA Establishment and pay the fee (was $6,493 in 2023) ; most domestic distributors do not need to pay the Establishment Fee.

Does a US Domestic Distributor have to have FDA Establishment?

Domestic Distributors and others do not need establishment with the FDA, which costs $6,493 in 2023.

What your carrier should know or needs to know.

Large carriers like UPS, FedEx and DHL have FDA specialists and supervisors you can appeal to. If you use ocean or truck or a small carrier they may need coaching on FDA entries to the ACE system. Provide your Initial Importer with the carrier’s contact information and the invoice used.

What causes US import delays for medical devices ?

To avoid delays and holds, The best action you can do as a sender or receiver is to make sure the commercial invoice is as complete as possible before the medical device is sent.
Contact your carrier or broker and request the commercial invoice and other required document be “electronically attached” to the shipment. Physical docs attached to the box are rarely noticed.
Unfortunately there are circumstances beyond our control like weather and a busy day in customs. If your carrier has online ship status, check whether it has lingered in a warehouse. Have your Initial Importer get the Entry Number and FDA Notice of Action and check ITACS.

Why doesn’t US Customs or FDA tell me when there is a problem ?

Often the invoice is not clear on who to contact; review a draft of the invoice with the sender before sending. Carriers often submit entry data to customs before the shipment arrives; check with your broker or carrier. Sometimes carriers are delayed. On rare occasions the inspector has a question and waits for answers. Sometimes carriers have a last minute shipping charge they want money for.

Shipping only one Medical Device to a friend.

For Personal Use as a Non-Food Product — for personal use as a medical device — Intended Use Code 100.010 . Customs and FDA have less stringent requirements when shipped for personal use.

How to help your broker comply with FDA when shipping medical devices.

If the broker or carrier only ships medical devices on occasion, have the Initial Importer review the invoice and provide the carrier the FDA-specific Affirmation of Compliance codes.

My medical device has been in customs for a month . What do I do?

Prayer is always good. Keep in mind that after 30 days most unresolved imports are returned to sender. Get status from broker or carrier. Find if hold is with customs or FDA. If FDA, have Initial Importer get entry number and the FDA Notice of Action(NOA). The NOA will have FDA agent name and contact, and reason for detention.

Why did the FDA close down the convent’s tailor shop?

Because it was found to be habit forming.

How can I avoid paying FDA Establishment Registration?

Domestic Distributors or US branch offices of a foreign company who do not otherwise modify devices can use an Initial Importer like MDPPS to avoid Establishment fees.

Who must list devices with the FDA?

These entities must list devices: Manufacturers, Contract Manufacturers, Specification Developers, Sterilizers. The Initial Importer and the commercial invoice needs the Listing Number from the manufacturer.

How can I minimize the cost of FDA Initial Importing?

1. Some Initial Importers like MDPPS discount coverage for an annual term.
2. Have the manufacturer complete the packaging, sterilizing and testing process to minimize freight and establishment before shipping to the US.

What if the manufacturer paid for FDA Establishment but no Establishment Number is assigned?

The FDA may take 2 months or more after receiving the establishment fee to assign the establishment number. The sender in the meantime should have on the invoice “Establishment Status is Active , awaiting assignment of registration number”.