What are the FDA Regulatory
Requirements for Importing
Medical Devices into the U.S.?
Carole C. Carey
carole.carey@fda.hhs.gov
Director, CDRH International Staff
U.S. FDA Center for Devices and Radiological
Health
Learning Objective
Have
a basic knowledge and
understanding of importation process
and the regulatory requirements for
medical devices before they may be
imported into the U.S.
U.S. Food & Drug Administration
22009 Sep 29 Edmonton, Oct 1 Vancouver
Outline
 Import
Program Mission & FDA Authority
 Role
of FDA ORA and relationship with
Customs Border Protection
 Importer
 Import
requirements /Import procedures
for Export
 Sampling
U.S. Food & Drug Administration
decisions & Automated Systems
32009 Sep 29 Edmonton, Oct 1 Vancouver
Mission of the
Import Program
 To
successfully assess, manage,
mitigate, and to the extent possible,
eliminate public health risks that FDAregulated imported products may pose
to U.S. consumers.
Medical devices, and electronic products that
emit radiation are FDA-regulated products and
are subject to examination by FDA when they
are being imported or offered for import into
the United States.
U.S. Food & Drug Administration
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FDA Import Authority
Section 801(a) - (d) FD&C Act

801(a) U.S. Customs will
notify U.S. FDA
regarding the entry of
regulated products,
which includes medical
devices.
U.S. Food & Drug Administration

801(b) U.S. FDA will
authorize U.S. Customs to
permit delivery of the
regulated products or to
refuse entry to the U.S.
FDA Import Authority
Section 801(a) - (d) FD&C Act
 801(c)
Owner or
consignee pays the
expense incurred
by FDA in
connection with
destruction or
reconditioning of
refused products
U.S. Food & Drug Administration
 801(d)(3)
discusses
the conditions for
importing devices
which are not
approved for
marketing in the U.S.
for subsequent
export use.
Import for Export
62009 Sep 29 Edmonton, Oct 1 Vancouver
Import for Export

The law permits U.S. firms to import components,
subassemblies, unfinished devices
to the U.S. for the purpose of “further processing”
or “incorporation” (to include packaging labeling
or sterilization) into medical devices
– Requires registration, and listing, and subject to
FDA audits
– Statement for intent to export
U.S. Food & Drug Administration
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Office of Regulatory
Affairs (ORA)
 ORA is
the lead office
for all FDA field
activities as well as
providing FDA
leadership on imports,
inspections, and
enforcement policy.
U.S. Food & Drug Administration
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Office of Regulatory
Affairs (ORA)
 ORA supports
the five FDA product centers by
– inspecting regulated products and
manufacturers,
– conducting sample analysis on regulated
products,
– reviewing imported products offered for entry
into the United States.
 ORA also
develops FDA-wide policy on
compliance and enforcement and executes FDA’s
Import Strategy and Food Protection Plans.
U.S. Food & Drug Administration
92009 Sep 29 Edmonton, Oct 1 Vancouver
Same Standards for
Domestic & Imported Devices
 All
imported products are required to meet
the same standards and regulations as
domestic goods.
– devices must be safe and effective
– radiation-emitting devices must meet
established standards
»products must contain informative and
truthful labeling in English.
U.S. Food & Drug Administration
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General Controls
(Class I, II, III Devices)

Basic authorities that
provide FDA with the
means to regulate
medical devices.
– Premarket notification or 510(k),
if not exempt
– Register and List
– Compliant Labeling
» Misbranding

Applies to all medical
devices regardless of
classification, are
subject to premarket
and postmarket
regulatory controls.
U.S. Food & Drug Administration
» Adulteration
– Quality Systems /GMP
– Records and Reports / (MDR)
» Report device failures
» Corrective action plans
– Postmarket studies, if required.
112009 Sep 29 Edmonton, Oct 1 Vancouver
What is Adulteration?
What is Misbranding?

Adulteration has to do with the content of a
product (such as the addition of a substance
which makes a product inferior, impure, not
genuine, etc.)

Misbranding has to do with statements on
labels or labeling that are false or
misleading.
U.S. Food & Drug Administration
122009 Sep 29 Edmonton, Oct 1 Vancouver
Foreign Manufacturers

Register Establishment and List Device (s).

In addition, must designate a United States agent.

As with domestic manufacturers, foreign manufacturing
sites are subject to FDA inspection.

Evidence they were produced in a facility which has
registered, licensed and/or listed its products with FDA is
required. For these products, the site-specific location
must be submitted as the FDA Manufacturer.
– The name and address of a corporate headquarters,
"trading company", or other intermediate supplier is
not acceptable.
U.S. Food & Drug Administration
132009 Sep 29 Edmonton, Oct 1 Vancouver
Initial Importer
 any
importer who furthers the marketing of
a device from a foreign manufacturer to the
person who makes the final delivery or sale
of the device to the ultimate consumer or
user
 does not repackage, or otherwise change the
container, wrapper, or labeling of the device
or device package.
U.S. Food & Drug Administration
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Initial Importer

Must register establishment

Subject to
– Medical Device Reporting (21 CFR 803)
» (maintain an MDR event file for each adverse event)
– Reports of Corrections and Removals (21 CFR 806)
» All product complaints (MDR and nonMDR event must
be forwarded to the manufacturer)
– Medical Device Tracking 21 CFR 821, if applicable
» (tracked through the distribution chain)
U.S. Food & Drug Administration
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Import Procedures
 U.S.
Importer posts bond, pays duty, and obtains
permit from U.S. CBP
 U.S.
CBP submits invoices of regulated products to
FDA
When an entry is filed with CBP, a copy of the entry is also
provided to the local FDA district office. The FDA
district office then determines if the product complies
with FDA requirements.
U.S. Food & Drug Administration
162009 Sep 29 Edmonton, Oct 1 Vancouver
Import Procedures (cont’d)

FDA decides whether to examine and/or sample
shipment , or to release shipment without
examination.
– In-compliance shipments - Released
– Violative samples - Detained
“Notice of FDA Action”
– Auto detention - All products from listed Exporters or
Exporting Countries are Automatically Detained without
sampling
Form FDA 2877 (Declaration for Radiation Standard) is required for
radiation-emitting electronic products entering the United States.
U.S. Food & Drug Administration
172009 Sep 29 Edmonton, Oct 1 Vancouver
Sampling Decisions
 FDA sets
 Risk
sampling priorities
analysis decision on product sampling
– Majority released without examination
 Examination
may be visual (labeling) or
laboratory analysis
 Some
products are 100% sampled, e.g.,
condoms
U.S. Food & Drug Administration
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Product Examined
or Sampled
 If
shipment passes examination – Admitted

If shipment fails – Entry denied and detained

Detained shipment:
- May be moved to nearby warehouse
- Requires FDA (not CBP) Release for destruction, reexport, or reconditioning.
 If
reconditioning passes – Entry allowed
- Reconditioning fails – Destroy or Re-export
U.S. Food & Drug Administration
192009 Sep 29 Edmonton, Oct 1 Vancouver
FDA Automated System
OASIS System (Operational and
Administrative System for Import
Support)

OASIS is an automated FDA system for
processing and making admissibility
determinations for shipments of foreign-origin,
FDA-regulated products seeking to enter U.S.
commerce.
U.S. Food & Drug Administration
202009 Sep 29 Edmonton, Oct 1 Vancouver
Using OASIS System
 Broker
 If
enters data into the CBP System
it is a device, CBP prompts Broker
 Broker
enters OASIS system, and enters data
 OASIS
System makes a risk assessment based on
Broker’s data – shipment released, or, shipment
detained for examination.
Import Refusals involving FDA-regulated products
are listed in Import Refusal Reports for OASIS,
updated monthly.
U.S. Food & Drug Administration
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U.S. Food & Drug Administration
222009 Sep 29 Edmonton, Oct 1 Vancouver
PREDICT System
 FDA's
new PREDICT risk-based screening
system for imports is coming soon.
 It will replace the admissibility screening function
of OASIS, FDA's legacy system.
 PREDICT will assist entry reviewers in targeting
higher-risk shipments for examination.
 It will also expedite the clearance of lower-risk
cargo, but only if accurate and complete data are
provided by importers and entry filers.
U.S. Food & Drug Administration
232009 Sep 29 Edmonton, Oct 1 Vancouver
Summary
Federal Food, Drug, and Cosmetic (FD&C) Act
and other laws apply equally to domestic and
imported products.
 FDA does not recognize regulatory approvals
from foreign countries.
 Medical devices and radiation-emitting products
must meet FDA regulations prior to the
importation into the United States.
 All foreign firms are required to both register their
establishments, identify a U.S. Agent, and
individually list their devices before they may
import them into the United States.

U.S. Food & Drug Administration
242009 Sep 29 Edmonton, Oct 1 Vancouver
References
http://www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/ImportingandExportingDevices/ucm050
126.htm
 Regulatory
Procedures Manual, Chapter 9,
Import Procedures
 FDA Investigations Operations Manual,
Chapter 6, Imports
 Import Alerts
 Import Program System Information
 Regulatory Procedures Manual.
 Food Drug & Cosmetic Act
U.S. Food & Drug Administration
252009 Sep 29 Edmonton, Oct 1 Vancouver
Compliance Policy Guides

Export of FDA Regulated Products from U. S. Foreign Trade Zones,
Compliance Policy Guide, Section 110.200 (CPG 7150.11)

Food and Drug Guaranty - Imports, Compliance Policy Guide, Section
110.500 (CPG 7153.10)

FDA Authority Over Products of Foreign Origin Located in Foreign
Trade Zones, Bonded Warehouses or on Bonded Carriers, Compliance
Policy Guide, Section 110.600 (CPG 7150.14)

Seizures by the U. S. Customs Service of Prohibited Articles of
Foreign Origin Not Intended for Entry into the United States,
Compliance Policy Guide, Section 110.700 (CPG 7153.08)

Imports, Post Detention Sampling, Compliance Policy Guide, Section
110.800 (CPG 7150.04)
Imported Products - Lack of English Labeling, Compliance Policy
Guide,
Section 110.900 (CPG 7150.15) 262009 Sep 29 Edmonton, Oct 1 Vancouver
U.S. Food & Drug
Administration

For more information…

FDA Office of Regulatory Affairs
Div. of Import Operation &
Policy, HFC-170
5600 Fishers Lane, Rockville,
MD 20850
(301) 443-6553 FAX (301) 5940413

FDA Center for Devices and
Radiological Health
Division of Small Manufacturers,
International and Consumer
Assistance
10903 New Hampshire Ave, Silver
Spring, MD 20993-0002
(800) 638-2041 FAX (301) 8478149.
Manufacturers outside the U.S.
should call (301) 796-7100
Email dsmica@fda.hhs.gov
U.S. Food & Drug Administration
272009 Sep 29 Edmonton, Oct 1 Vancouver
Thank you!