Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products that emit radiation into the U.S., the product must meet FDA regulatory requirements. FDA does not recognize regulatory approvals from other countries. The following is a summary of FDA requirements for medical devices and products that emit radiation.
Foreign manufacturers must meet applicable United States (U..S.) medical device regulations in order to import devices into the U.S. even if the product is authorized for marketing in another country. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval, if applicable. In addition, the foreign manufacturers must designate a United States agent. As with domestic manufacturers, foreign manufacturing sites are subject to FDA inspection. Information on U.S. regulatory requirements can be found in the Device Advice section.
The initial importer of the device must register its establishment with FDA. An initial importer is 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, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. Registration information can be found under Establishment Registration.
Initial importers are also subject to Medical Device Reporting (MDR) under 21 CFR 803, Reports of Corrections and Removals under 21 CFR 806, and Medical Device Tracking under 21 CFR 821, if applicable. Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions. The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and nonMDR events) must be forwarded to the manufacturer. Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain.
Products that emit radiation
Foreign manufacturers that export electronic products (medical device or non-medical) that emit radiation to the United States are subject to the requirements of the Federal Food, Drug, and Cosmetic Act, Subchapter C - Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968). These requirements include performance standards, labeling, and submission of radiation safety product reports. Guidance on these requirements can be found on the Internet under Electronic Product Radiation Control. When manufacturers submit radiation safety product reports, the reports are entered into a database and assigned an accession number (file point). Importers may submit radiation safety product reports on behalf of manufacturers.
All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry.
The major responsibility of CBP is to administer the Tariff Act of 1930 as amended. Primary duties include assessment and collection of all duties, taxes, and fees on imported merchandise; administration and review of import entry forms; the enforcement of CBP and related laws; and administration of certain navigation laws and treaties. There is a working agreement between FDA and CBP for the cooperative enforcement of Section 801 of the FD& C Act.
The import process begins with the importer or filer submitting the necessary entry information to the local CBP district office. For those entries not filed electronically, a paper entry consisting of the commercial invoice, CBP entry forms CF3461/3461ALT and/or CF7501 or documentation that would need to be provided by the importer or filer.
Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. FDA, CDRH, issued a letter which clarifies what entry information should be provided at the time of entry. The correct information will help expedite the entry review process and increase the likelihood that your shipment may be processed based on import system screening and not held for further FDA entry review. Please note that the product code provided to CBP must include a two digit prefix identifying the medical specialty in addition to the three letter code. The medical specialty codes are as follows:
|77||Ear, Nose, and Throat||Part 874|
|78||Gastroenterology and Urology||Part 876|
|79||General and Plastic Surgery||Part 878|
|80||General Hospital||Part 880|
|85||Obstetrics and Gynocology||Part 884|
|89||Physical Medicine||Part 890|
For example, the device product code provided to CBP for sunglasses would be 86HQY. Please refer to "Classify Your Medical Device" on FDA's Device Advice website for further guidance on device classification and product codes.
Importers of radiation emitting electronic products subject to a federal performance standard are required to submit a written declaration on "Declaration of Products Subject to Radiation Control Standards," form FDA-2877, along with other import entry information, including accesssion number, if appropriate, through CBP to the appropriate FDA district office. Electronic products that fail to comply with the applicable performance standard or do not have a certification label or tag (21 CFR 1010.2) affixed to each product shall be refused entry. FDA, CDRH, has issued a letter which clarifies what entry information should be provided at the time of entry for medical and non-medical radiation emitting electronic products.
- Letter to Industry about Import Entry Review Process (September 6, 2011)
Most importers ask that domestic customhouse brokers (or filers) complete these forms electronically and make the submissions on their behalf. Filers have access to the Operational and Administrative Systems for Import Support (OASIS), the FDA computerized import system. The OASIS program is an electronic interface between FDA and the CBPs Automated Commercial System (ACS). OASIS is an on-line interactive and automated system, which replaced the process of reviewing the paperwork for import entries manually.
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. The FD&C Act authorizes FDA to detain a regulated product that appears to be out of compliance with the Act. If a product appears to be out of compliance, the FDA district office will issue a "Notice of FDA Action" specifying the nature of the violation to the owner or consignee. The owner or consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another "Notice of FDA Action" refusing admission to the product. The product then has to be exported or destroyed within 90 days. Failure to do so within 90-days may result in issuance of a Customs Redelivery Notice and an assessment for liquidated damages for up to 3 times the value of the lot.
Upon entry, FDA may examine certain devices to assure their safety and effectiveness. When this occurs, FDA will issue a notice to the importer of a record on a form titled "Notice of FDA Action." Sampling may involve examining the product at the port of entry or physical collection of a statistical portion of the lot for analysis by an FDA laboratory. If the sample is violative, or if the sample is determined to be out of compliance with required specifications, the device will be detained and the importer of record will be issued a "Notice of FDA Action" indicating that the article is being detained due to the appearance of a violation under the FD&C Act. The "Notice of FDA Action" will state the specific violations to the FD&C Act.
Under certain conditions, the importer of record of a device that has been detained, is given an opportunity to submit application for authorization to bring the device into compliance with the FD&C Act. If FDA permits reconditioning, another sample may be collected and analyzed after reconditioning. If the device is then determined to be in compliance, it will be released. Only the FDA District Office at the port of entry has the authority to authorize reconditioning and/or to release the shipment. You must provide the appropriate documentation or bring the products into compliance under the authorization from the District Office. When contacting the District Office, you should ask for the Compliance Office and provide the entry number and/or sample number as a reference.
Additional information on importation of medical devices can be found in the following documents:
- Regulatory Procedures Manual, Chapter 9, Import Procedures
- FDA Investigations Operations Manual, Chapter 6, Imports
- Import Alerts
- Import Program System Information
A firm may import device parts, components, subassemblies, etc. for further processing or incorporation into unapproved devices which are to be subsequently exported. A firm may not import a finished unapproved device without prior marketing clearance, even if the device is to be imported solely for subsequent export. The terms "further processing" and "incorporation" as detailed in the Regulatory Procedures Manual is rather broad in its interpretation. For example, a device imported for further packaging or labeling would fall into this category; a device which is simply stored without any further action prior to export would not fall into this category.
The provisions for import for export under section 801 of the FD&C Act have been amended by the section 322 of Bioterrorism Act of 2002. Importers wishing to import devices (including components or an accessory of a device or other article of a device requiring further processing, which is ready or suitable for use for health-related purposes) that are intended for further processing or incorporation into another product and subsequest export must provide FDA with certain information at the time of initial importation. The information includes a statement that confirms the intent to further process such article or incorporate such article into a product to be exported and identifies entities in the chain of possession of the imported article. At the time of initial importation and before delivery to the importer, initial owner, or consignee, a bond must be executed providing for liquidated damages in the event of default, in accordance with Bureau of Customs and Border Protection (formerly called U.S. Customs) requirements. The initial owner or consignee of the article must maintain records of the use and/or destruction of such imports and must submit the records or a report to FDA upon request. Additional guidance on import for export can be found in Chapter 9 of the Regulatory Procedures Manual, Import for Export.
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)
Regulations 21 CFR 1, Subpart E--Imports and Exports
- Sec. 1.83 - Definitions
Sec. 1.90 - Notice of sampling Sec. 1.91 - Payment for samples Sec. 1.94 - Hearing on refusal of admission Sec. 1.95 - Application for authorization to relabel and recondition Sec. 1.96 - Granting of authorization to relabel and recondition Sec. 1.97 - Bonds Sec. 1.99 - Costs chargeable in connection with relabeling and reconditioning inadmissible imports