what are the fda regulatory requirements for importing medical devices into the u.s.? carole c....
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What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?
What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?
Carole C. [email protected]
Director, CDRH International StaffU.S. FDA Center for Devices and Radiological
Health
Carole C. [email protected]
Director, CDRH International StaffU.S. FDA Center for Devices and Radiological
Health
U.S. Food & Drug Administration
22009 Sep 29 Edmonton, Oct 1
Vancouver
Learning ObjectiveLearning 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.
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
32009 Sep 29 Edmonton, Oct 1
Vancouver
OutlineOutline
Import Program Mission & FDA Authority Role of FDA ORA and relationship with
Customs Border Protection Importer requirements /Import procedures Import for Export Sampling decisions & Automated Systems
Import Program Mission & FDA Authority Role of FDA ORA and relationship with
Customs Border Protection Importer requirements /Import procedures Import for Export Sampling decisions & Automated Systems
U.S. Food & Drug Administration
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Vancouver
Mission of theImport ProgramMission of theImport Program
To successfully assess, manage, mitigate, and to the extent possible, eliminate public health risks that FDA-regulated 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.
To successfully assess, manage, mitigate, and to the extent possible, eliminate public health risks that FDA-regulated 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
FDA Import AuthorityFDA Import Authority Section 801(a) - (d) FD&C ActSection 801(a) - (d) FD&C Act
801(a) U.S. Customs will 801(a) U.S. Customs will notify U.S. FDA notify U.S. FDA regarding the entry of regarding the entry of regulated products, regulated products, which includes medical which includes medical devices.devices.
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.
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.
U.S. Food & Drug Administration
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FDA Import AuthorityFDA Import Authority Section 801(a) - (d) FD&C ActSection 801(a) - (d) FD&C ActFDA Import AuthorityFDA Import Authority Section 801(a) - (d) FD&C ActSection 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
801(c) Owner or consignee pays the expense incurred by FDA in connection with destruction or reconditioning of refused products
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
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
U.S. Food & Drug Administration
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Import for ExportImport 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
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)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.
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)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.
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
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Same Standards forDomestic & Imported DevicesSame Standards forDomestic & 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.
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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Vancouver
General Controls(Class I, II, III Devices)General Controls(Class I, II, III Devices)
Basic authorities that provide FDA with the means to regulate medical devices.
Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls.
Basic authorities that provide FDA with the means to regulate medical devices.
Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls.
– Premarket notification or 510(k),
if not exempt
– Register and List
– Compliant Labeling
» Misbranding
» Adulteration
– Quality Systems /GMP
– Records and Reports / (MDR)
» Report device failures
» Corrective action plans
– Postmarket studies, if required.
– Premarket notification or 510(k),
if not exempt
– Register and List
– Compliant Labeling
» Misbranding
» Adulteration
– Quality Systems /GMP
– Records and Reports / (MDR)
» Report device failures
» Corrective action plans
– Postmarket studies, if required.
U.S. Food & Drug Administration
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What is Adulteration? What is Misbranding?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.
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
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Foreign ManufacturersForeign 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.
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
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Initial ImporterInitial 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.
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 ImporterInitial 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)
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 ProceduresImport 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 When an entry is filed with CBP, a copy of the entry is also provided to the local FDA district office. The FDA also provided to the local FDA district office. The FDA district office then determines if the product complies district office then determines if the product complies with FDA requirements.with FDA requirements.
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 When an entry is filed with CBP, a copy of the entry is also provided to the local FDA district office. The FDA also provided to the local FDA district office. The FDA district office then determines if the product complies district office then determines if the product complies with FDA requirements.with FDA requirements.
U.S. Food & Drug Administration
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Import Procedures (cont’d) 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
– 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.
FDA decides whether to examine and/or sample shipment , or to release shipment without examination.– In-compliance shipments - Released
– Violative samples - Detained
– 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.
“Notice of FDA Action”
U.S. Food & Drug Administration
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Sampling Decisions Sampling Decisions
FDA sets sampling priorities Risk 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
FDA sets sampling priorities Risk 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 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, re-export, or reconditioning.
If reconditioning passes – Entry allowed
- Reconditioning fails – Destroy or Re-export
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, re-export, or reconditioning.
If reconditioning passes – Entry allowed
- Reconditioning fails – Destroy or Re-export
U.S. Food & Drug Administration
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FDA Automated SystemFDA Automated System
OASIS System (Operational andAdministrative 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.
OASIS System (Operational andAdministrative 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
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Using OASIS SystemUsing OASIS System
Broker enters data into the CBP System
If 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.
Broker enters data into the CBP System
If 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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Vancouver
U.S. Food & Drug Administration
232009 Sep 29 Edmonton, Oct 1
Vancouver
PREDICT SystemPREDICT 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.
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
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SummarySummary 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.
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
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Vancouver
Referenceshttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.htm
Referenceshttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.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
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
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Vancouver
Compliance Policy GuidesCompliance 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)
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)
U.S. Food & Drug Administration
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For more information…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) 594-0413
FDA Office of Regulatory Affairs
Div. of Import Operation & Policy, HFC-170
5600 Fishers Lane, Rockville, MD 20850
(301) 443-6553 FAX (301) 594-0413
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) 847-8149.
Manufacturers outside the U.S. should call (301) 796-7100
Email [email protected]
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) 847-8149.
Manufacturers outside the U.S. should call (301) 796-7100
Email [email protected]
Thank you!