Importing Medical Devices

Into the United States

Terri T. Garvin

Consumer Safety Officer

Division of Industry and Consumer Education

Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Annual Percentage of

Imported FDA Commodities

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Learning Objectives

1. Describe the import entry process

2. Identify common entry errors that may lead 

to import delays

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FDA Import Entry Process

FDA 

screens the data

FDA 

generates 

an import 

disposition 

& sends it to 

CBP

CBP sends message 

back to the broker

NO

Incomplete data 

prompts error 

message back to 

filer

CBP* data 

validation

Submission 

of entry data 

by the broker

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FDA Import Entry Process: 

Submitting Entry Data

Filer obtains data required by 

Customs and Border Protection

(19 CFR* 142.3)

Filer submits data to Customs 

Broker licensed by Customs and 

Border Protection (CBP)

Customs Broker assigns 

Harmonized Tariff Schedule (HTS) 

codes, enters code and mandatory 

product data into CBP’s ACE** 

portal

*Code of Federal Regulations

**Automated Commercial Environment 

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FDA Import Entry Process

FDA 

screens the data

FDA 

generates an 

import 

disposition 

& sends it to 

CBP

CBP sends message 

back to the broker

NO

Incomplete data 

prompts error 

message back to 

filer

CBP* 

performs 

syntax 

data 

validation

Submission of entry 

data by the broker

*Customs and Border Protection

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CBP Data Validation

• CBP conducts syntax validation of import entry (article) 

lines:

– Verify each entry (article) line for data completeness

– Determine entry (article) status using “other government 

agency” (OGA) Flags

• Entry (article) lines regulated by FDA receive FDA OGA Flag

– If data are incomplete, entry (article) is returned to filer

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CBP Data Validation: FDA Flags

FDA

FLAG

Is it regulated? Example

FD*1

May or may not be regulated by FDA: If 

regulated by FDA, submit entry 

information; if not regulated by FDA, 

disclaim

Certain chemicals used in manufacturing drug 

products vs. industrial use; safety goggles for medical 

use vs. non-medical use

FD2 Regulated by FDA, but is not 

food: Submit entry information

Medical Devices, Drugs, Tobacco, and Cosmetics

FD3

May or may not be a food product: If 

yes, submit Prior Notice (PN) and entry 

information; if no, disclaim

Salt used for flavoring food vs salt used for treating 

road surfaces

FD4 Food product: Submit PN and entry 

information

Fish and seafood, live food animals, dairy products, 

shell eggs, fruits, vegetables, food and feed 

ingredients, food and feed additives, infant formula, 

beverages (including alcoholic beverages and bottled 

water), bakery goods, snack foods, candy, canned 

foods, and dietary supplements and dietary 

ingredients.

*An FDA flag is 

assigned a file 

descriptor (FD) 

number, i.e. FD1

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FDA Import Entry Process

FDA 

screens the 

data

FDA 

generates 

an import 

disposition 

& sends it 

to CBP

CBP sends message 

back to the broker

NO

Incomplete data 

prompts error 

message back to 

filer

CBP 

performs 

syntax data 

validation

Submission of entry 

data by the broker

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FDA Screens the Data

• FDA Reviews the Entry (Article) Data 

• FDA determines if all required data to meet regulatory 

requirements have been provided

– FDA may request additional data needed to meet regulatory 

requirements or request sample for examination

– Data can be uploaded electronically using FDA’s Import 

Trade Auxiliary Communications System (ITACS)

– ITACS can also be used to check the status of an entry 

(article) 10
FDA Import Entry Process

FDA 

screens the data

FDA 

generates 

an import 

disposition 

and sends it 

to CBP

CBP sends message 

back to the broker

NO

Incomplete data 

prompts error 

message back to 

filer

CBP 

performs 

syntax data 

validation

Submission of entry 

data by the broker

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To generate an import disposition:

1. FDA reviews entry (article) for

 Data required for all FDA regulated articles (products), (21 CFR 1.72)

 Data Required by CDRH*for medical devices, (21 CFR 1.76)

Import Disposition

*Center for Devices and Radiological Health

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Import Disposition

Data required for all FDA regulated articles (product)

21 CFR 1.72

• Product-identifying information:

– FDA country of production

– Complete FDA product code

– Full intended use code

• Importer of Record Contact Information

– Email address and telephone number

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If applicable, Data required by CDRH for Medical 

Devices 21 CFR 1.76

• Registration and Listing Number

• Investigational Device Information

• Premarket number

• Component affirmation

Import Disposition

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If applicable, data required for Medical Devices

21 CFR 1.76

• Lead wire/patient cable performance standard affirmation

• Impact resistance lens affirmation of compliance with 21 CFR 801.40

• Convenience kit affirmation

If applicable, data required for Radiation-Emitting Electronic Products 

21 CFR 1.76

• Radiation-emitting electronic products declarations in Form 2877

Import Disposition

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Data required by CDRH for Medical Devices

• Determine regulatory requirements based on product 

classification

• Use CDRH’s Product Classification Database to identify product 

classification and other regulatory requirements

• Use Affirmation of Compliance Codes (A of C) to designate 

regulatory requirements

Import Disposition

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CDRH Device Regulatory Requirements: 

Product Classification Database

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Example:

Product 

Classification 

Record

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CDRH Regulatory Requirements: 

Product Classification Database

Use Device Classification Information To:

• Identify Premarket Number:

Premarket Notification [510(k)]

Premarket Approval (PMA) Application

Humanitarian Device Exemption (HDE)

De Novo Classification

Exempt (3-letter product code)

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CDRH Regulatory Requirements: 

Product Classification Database

Use Device Classification Information To:

• Identify Registration and Listing Numbers for:

Foreign manufacturer

Foreign exporter

Initial importer (registration only)

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CDRH Regulatory Requirements: 

Affirmation of Compliance Codes

Use Affirmation of Compliance (A of C) codes to 

designate regulatory requirements

– A of C Codes for Medical Devices

– A of C Codes for Radiological Health Products

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Example: Medical Device

Affirmations of Compliance Codes 

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Example: Radiological Health Products 

Affirmations of Compliance Codes

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Example: Import Scenarios

Intended Use

(see PG01 for 

definitions)

Import Scenarios Mandatory 

Affirmations

Conditional* 

Affirmations 

Optional 

Affirmations

081.001 or 

UNK

-Standard import of a foreignmanufactured device, 

accessories, or components 

regulated as a finished device

-Import of refurbished device

-Import of a reprocessed 

device

DEV, DFE, LST IRC, LWC, PM# DI

081.002** Import of a foreignmanufactured device for 

domestic refurbishing

DEV, DFE, LST IRC, LWC, PM# DI

*Conditional affirmations are required if applicable to the product being declared for entry

**Additional info may be needed at time of entry for FDA to make a final admissibility decision

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To generate an import disposition:

1. FDA reviews entry (article) for

 Data required for all FDA regulated articles (products), (21 CFR 1.72)

 Data Required by CDRH*for medical devices, (21 CFR 1.76)

2. FDA determines Notice of Action:

 Release the product

 Request additional information or sample evaluation; or

 Request detention of product

3. FDA issues Notice of Action to CBP and Importer of Record

Import Disposition

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FDA Import Entry Process

FDA 

screens the data

FDA 

generates 

an import 

disposition 

& sends it 

to CBP

CBP sends 

message back 

to the broker

NO

Incomplete data 

prompts error 

message back to 

filer

CBP 

performs 

syntax data 

validation

Submission of entry 

data by the broker

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CBP sends electronic disposition message to:

• Customs Broker

• Filer/Importer of Record

• Owner or Consignee

CBP Sends Message

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Common Entry Errors

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Common Entry Errors

Submitting

• Incorrect Affirmation of Compliance Codes

• Incorrect Manufacturer Information

• Incorrect Product Code

• Incorrect Product Quantity

• Incomplete Information 

www.fda.gov/industry/regulated-products/medical-device-common-entry-errors

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Summary

• FDA reviews medical device import information

• Regulatory requirements are based partly on product 

classification

• Affirmation of Compliance codes correspond with 

regulatory requirements

• Entry errors may lead to import delays

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Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 100 modules - videos, audio recordings, PowerPoint presentations, 

software-based “how to” modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

 Phone: 1-800-638-2041 or (301) 796-7100 (Live Agents 9 am – 12:30 pm; 1 – 4: 

30 pm ET)

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Your Call to Action

Prior to importing your products, do these three tasks:

1. Ensure your product meets U.S. regulatory 

requirements

2. Register and list, if required

3. Provide the applicable entry information to your 

custom broker

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