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Importing Medical Devices into the United States

Slide 1

Hello, my name is Terri Garvin. I am a Consumer Safety Officer in the Division of Industry and Consumer 

Education at FDA’s Center for Devices and Radiological Health, or CDRH. Welcome to CDRH Learn, CDRH's 

resource for multimedia industry education. The title of this presentation is, "Importing Medical Devices 

into the United States." 

Slide 2

Did you know that in 2017, medical devices made up the largest FDA product type imported into the 

United States? 49% of all FDA regulated imports were medical devices. After viewing this program, I hope 

that you will have a better understanding of the Import process and the entry information needed to 

successfully import your devices without delay. 

Slide 3

The learning objectives for this module are to describe the import entry process for medical devices and to 

recognize common entry errors that may lead to import delays.

Slide 4

This slide shows a flowchart that describes the FDA Import Entry Process. Over the course of the next few 

slides, I will present this process beginning with the submission of the required entry data by your customs 

broker through the final disposition of your entry.

Slide 5

As noted in the previous slide, the filer obtains the data required by Customs and Border Protection, or 

CBP, and submits it to his or her custom’s broker in accordance with Title 19 Code of Federal Regulations 

Part 142. Customs Brokers are responsible for using reasonable care to enter, classify, and determine the 

value of imported goods. They are also responsible for providing any other information necessary to 

enable CBP to properly assess duties and determine other applicable legal requirements. 

The Customs Broker determines the classification of the import using the Harmonized Tariff Schedule, or 

the HTS Code. The HTS Code is used to determine the tariff duties to be assessed and to flag which imports 

are subject to FDA Admissibility review. The Customs Broker is responsible for entering this data into CBP’s 

Automated Commercial Environment, or the ACE System. 

Slide 6

Once the entry has been filed with CBP, CBP then performs syntax data validation.

Slide 7 

CBP conducts syntax validation of import entry or article lines by verifying each entry line for data 

completeness and determines the entry status using “other government agency” or OGA Flags in 

accordance with Title 19 CFR Section 142.42. Entry lines regulated by the FDA receive an FDA OGA Flag. If 

there is incomplete data, the entry is returned to the filer. 

Slide 8

Presented on this slide is a table showing the flags associated with FDA regulated commodities. As you can 

see, the file descriptor, FD2, indicates that the article is under FDA’s jurisdiction.

Slide 9
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At this point in the entry process, once CBP has performed the syntax data validation, FDA then screens 

the data specific to the device for entry into the U.S. 

Slide 10

During the screening process, FDA reviews the entry and determines if the required data are present. If 

there are missing data, FDA may request additional information needed to meet regulatory requirements,

or request a sample for examination. Data or documents submitted in response to a request for additional 

information may be uploaded electronically using FDA’s Import Trade Auxiliary Communications System, or 

ITACS. You can use ITACS to determine the status of your entry. 

Slide 11

Upon completion of the import entry screening, FDA generates an import disposition and sends it to CBP.

Slide 12

To generate the import disposition of a medical device entry, FDA must first review the data required for 

all FDA regulated products, as well as the specific data required for medical devices. 

Slide 13

FDA reviews the entry for required data. This includes product-identifying information, which consists of

the FDA Country of Production, the Complete FDA Product Code, and the Complete Intended Use Code. 

The product code is generated using the product code builder. The complete intended use code is found in 

Appendix R of FDA’s Supplemental Guide. FDA also reviews the Contact Information for the Importer of 

Record, which includes their email address and telephone number.

Slide 14

In accordance with 21 CFR Section 1.76, all device entries require the following information, if applicable:

registration and listing number; investigational device information; premarket number; or component 

affirmation.

Slide 15

Additionally, the entry must also include affirmations of compliance for specific device types as applicable. 

This device types are: Lead wire/patient cables, Impact resistance lenses, and Convenience Kits. And 

specific to radiation-emitting electronic products, 21 CFR Section 1.77 requires that an ACE filer submit all 

of the declarations in Form 2877, indicating that applicable performance reports have been submitted.

Slide 16

To determine which of the data elements addressed in 21 CFR Section 1.76 are applicable to your entry, 

you must first determine the classification of the device. This can be done by using the classification 

database to find your device and the associated regulatory requirements. The Affirmation of Compliance 

Codes are used to then demonstrate the regulations applicable to your device. A link to the database is 

included on this slide.

Slide 17

This is a screen shot of CDRH’s Product Classification Database. The device search field is highlighted on 

the screen. Enter either a general name for the device or a term that describes its intended use. The next 

slide provides an example of one of the product records which resulted from a search using the term 

“orthosis”. 

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Note the red highlighted sections of this device record. Device records provide the device name and 

description, the 3-letter product code assigned to the device, the device submission type, and Information 

regarding registration and listing requirements as indicated in the red highlighted box at the bottom of the 

screen.

Slide 19

Use the device information found in the product classification database record to identify the premarket 

number, if any. Identify the premarket submission type which can be a Premarket notification, a Premarket 

application, a Humanitarian Device Exemption, or a De Novo Classification. The product may be exempt 

from premarket submission requirements and instead of a premarket number, you will identify your 

product by the 3-letter product code.

Slide 20 

Use the device classification information to identify both the Foreign Manufacturer’s establishment 

registration and device listing numbers, the Foreign Exporter’s establishment registration and device listing 

numbers, or the Initial Importer’s establishment registration number. Initial importers are not required to 

list. 

Slide 21

Affirmations of Compliance provide CDRH with the information it uses to make admissibility 

determinations. There are specific codes for medical devices and radiological health products. The next 

two slides present the codes for the respective product types.

Slide 22

The codes for medical devices are provided on this slide. The highlighted codes represent the ones most 

often required for entry. The Code DEV represents the registration number for the foreign manufacturer, 

the code LST represents the device listing number and the code PM number represents the premarket 

submission number associated with a particular device. 

Slide 23

This slide lists the codes associated with Radiological Health products. In the table, Code IFE represents, 

“Import for Export”. This code can be used for medical devices as well. It indicates that the device will be 

imported for further processing, and upon completion of that processing, it will be exported. 

Slide 24

Thus far, we identified the data requirements for imports in general, as well as the requirements specific to 

CDRH’s regulatory requirements. This is an example of an entry that is identified as a standard import of a 

foreign manufactured device. The intended use code for such an entry is 081.001. Further identification of 

this device is needed to determine which codes are considered mandatory, conditional or optional. 

Slide 25

We discussed the entry process which begins with FDA screening the required data for the entry. Once 

FDA has completed its screening for the required data, it continues with the Import Disposition by 

determining the notice of action. The notice of action will be either to release the product, request 

additional information, request a sample for evaluation, or request detention of the entry. After FDA has 

determined the notice of action, FDA will then issue the notice to CBP and the Importer of Record.

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Going back to our flow chart, once FDA generates the import disposition and sends it to CBP, CBP then 

sends the message to the broker and others as required. 

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In addition to the Customs Broker, CBP also sends an electronic disposition message to the Filer or 

Importer of Record and to the Owner. This completes the FDA import entry process.

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As you can see, the import entry process involves a number of steps, and not surprisingly, we see a 

number of common errors that occur. Let’s review these now so that you can avoid these errors.

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Some common entry errors include submitting the incorrect Affirmation of Compliance code, the incorrect 

manufacturer information, the incorrect product code, the incorrect product quantity, or incomplete 

information. If you can avoid these errors, you’re much more likely to be successful in importing your 

medical devices products without running into problems along the way. More information about common 

entry errors may be found at the link on this slide.

Slide 30

Let’s review what we’ve covered in this module. FDA reviews import entry data for complete and correct

information associated with the product submitted for entry. Regulatory requirements are based partly on 

product classification. 

Affirmation of Compliance codes correspond with these regulatory requirements. And finally, entry errors, 

due to incomplete data or other reasons, may lead to import delays.

Slide 31

CDRH provides multiple opportunities for industry education. CDRH Learn is an innovative educational 

tool, which consists of learning modules describing many aspects of medical device and radiation emitting 

product regulations, covering both premarket and post-market topics. Modules are provided in various 

formats, including videos, audio recordings, and slide presentations.

Device Advice is a text-based resource that explains many aspects of medical device laws, regulations, 

guidance, and policies, covering both premarket and post-market topics.

In addition, the Division of Industry and Consumer Education (D-I-C-E) answer's questions, by phone and 

email, from industry and consumers related to medical devices. The web links and contact information to 

these resources are provided on this slide.

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After viewing this presentation, your call to action is to ensure that prior to submitting your entry for 

import, you ensure that your product meets U.S. Regulatory Requirements, that the proper parties are 

registered and have completed a device listing, if required; and that applicable Entry data are provided to 

your Customs Broker. Thank you for watching.

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