Importing Medical Devices Into the U.S.: What The FDA Checks at the Border

The short version

When a medical device arrives at a U.S. port, The FDA checks four things: that the firms involved are registered and the device is listed, that any required 510(k) or PMA is in place, that the manufacturer or product is not on an Import Alert, and that the device holds up to the field exams and sample analysis The FDA conducts to check standards and labeling. A device that is missing required registration and listing, or a required premarket clearance or approval, is subject to refusal.

Most delays come from one thing: entry data that does not match The FDA’s records. The rest of this guide shows you what gets compared and how to get ahead of it.

Is your product a medical device?

The Center for Devices and Radiological Health (CDRH) runs the device program. Under the Federal Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article that is labeled or used for diagnosis, treatment, or prevention, or to affect the structure or function of the body.

A product that meets the definition is subject to The FDA’s laws and regulations before, during, and after it is offered for sale or use. The import check is one checkpoint in a longer process, not the whole process.

Two details worth knowing:

• Counterfeit devices are a defined category. A counterfeit device is one that, without authorization, bears another maker’s identifying mark or uses that maker’s design, and falsely suggests that maker produced it.
• Section 513(g) of the Act provides a way to obtain The FDA’s views on the classification and regulatory requirements for a device. If you are unsure how your device is classified or what applies to it, that is the route the page points to.

What The FDA verifies at importation

The page gives Import Alert 89-04 as an example. It lists foreign manufacturers not in compliance with medical device Good Manufacturing Practices. The page links this to the Quality Management System Regulation (QMSR).

How entry reviewers match your data

Entry reviewers compare what is declared at entry against The FDA’s internal systems. The data points are:

1. Declared manufacturer
2. Declared importer or consignee
3. Product description
4. Affirmation of Compliance (A of C) codes

If everything matches, compliance is verified. If it does not, The FDA may ask for more information or detain the product.

Accurate entry data increases the likelihood that a shipment is processed electronically and not held for manual review. The FDA’s PREDICT screening tool can verify declared information against internal data systems. Inaccurate or incomplete information may delay the review of your entry.

Registration and listing

Establishments that produce or distribute devices for commercial distribution in the U.S. must register every year. Most must also list their devices and activities.

At entry, The FDA checks that:

• The declared manufacturer and shipper are registered
• The importer is registered
• The product description matches the listing in the CDRH database

You can look up a firm’s registration in the public registration and listing database. The listing number is different: you need to get it from the firm that listed the device.

Classification and premarket submissions

Devices fall into Class I (lowest risk), Class II, or Class III (highest risk). Some devices are unclassified. The Product Classification Database helps you determine the submission type required for a device.

To find your device’s class and submission type, use The FDA’s Product Classification Database: search for your device, open the matching result, and view the device class. Searchable 510(k) and PMA databases are also public.

At entry, The FDA verifies the declared 510(k) or PMA number against CDRH data. A missing, incomplete, or inaccurate number can delay the shipment. A device that requires a PMA or 510(k) and does not have one is subject to refusal.

Affirmation of Compliance (A of C) codes

A of C codes are three-letter codes provided at entry to help The FDA review the shipment. Some are mandatory in certain cases and others are not required. Submitting voluntary codes may expedite initial screening and review of your entry. The FDA publishes a reference page with each code’s description.

Special cases the page flags

• Radiation-emitting devices may have additional requirements, covered on a separate page.
• Combination products (drug, device, and/or biologic) are assigned a lead center based on primary mode of action. See the combination products FAQ.
• Decorative contact lenses are regulated as medical devices, with the same safety and effectiveness oversight as vision-correcting lenses.
• Personal importation has its own page.
• Labeling is covered on the Device Labeling page.
• UDI at entry: the page links a CBP bulletin (CSMS #56355955) on The FDA’s Unique Device Identifier review during import entry.

Pre-shipment checklist

•  Confirm the product meets the definition of a medical device and how it is classified (Section 513(g) lets you request The FDA’s view)
•  Look up the class and submission type in the Product Classification Database
•  Confirm the 510(k) or PMA number, if required, and that it matches CDRH data
•  Confirm the manufacturer and shipper are registered
•  Confirm the importer is registered
•  Confirm the device is listed and the product description matches the listing
•  Get the listing number from the listing firm
•  Check that the manufacturer and product are not subject to an Import Alert
•  Declare manufacturer, importer or consignee, and product description accurately at entry
•  Include the correct A of C codes, mandatory and voluntary
•  Review The FDA’s Medical Device Common Entry Errors page

Who to contact at The FDA

The Division of Industry and Consumer Education (DICE) in CDRH handles device and radiation product questions. Phone: (800) 638-2041 or (301) 796-7100. Email: DICE@fda.hhs.gov.

FAQs

Need a hand with your device shipments?

If you are sorting out registration, listing, or entry data for a medical device, get in touch and we will point you in the right direction. You can also see our medical device services.