This page will provide an overview of medical and non-medical radiation-emitting electronic products and the requirements that FDA verifies/enforces at the time they are imported or offered for import into United States. To import radiation-emitting products (medical and non-medical) you should first understand what these products are and their requirements.
The Center for Devices and Radiological Health (CDRH) is the FDA center responsible for overseeing the radiation-emitting products program. Visit the Radiation-Emitting Products web page for more information.
What is a radiation-emitting electronic product?
FDA defines a radiation-emitting electronic product as any electrically-powered product that can emit any form of radiation on the electromagnetic spectrum. These include a variety of medical and non-medical products such as mammography devices, magnetic resonance imaging (MRI) devices, laser toys, laser pointers, liquid crystal displays (LCDs), and light emitting diodes (LEDs). View examples of radiation-emitting electronic products.
Radiation-Emitting Product Requirements Verified at the time of Importation
At the time of importation, FDA will verify compliance with the following requirements for all radiation-emitting products:
FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert. For example, import alert 95-04 lists certain laser products that fail to comply with applicable performance standards and reporting requirements.
When applicable, FDA will verify the manufacturer, report accession number, model designation, and annual report declared at the time of entry.
For additional information on reporting LEDs to FDA, review the CSMS message that was issued on June 6, 2017.
CDRH also has useful information regarding LEDs and LCDs. Visit the Televisions and Video Display Monitors page for more information.
How can I determine specific product requirements for radiation-emitting electronic products?
Electronic products are subject to the Electronic Product Radiation Control (EPRC) provisions as defined in the Federal Food Drug and Cosmetic Act (FD&C Act), Chapter 5, Subchapter C, Sections 532 – 538. Radiation-emitting electronic products are regulated by FDA and are required to comply with the general requirements found in 21 CFR 1000-1005. For more information on products subject to performance standards visit the Products Subject to Performance Standards page.
Reporting requirements for radiation-emitting products can be found in Table 1 of 21 CFR 1002.1.
To search for product names and their associated product codes, the radiation type, definition, and applicable performance standards visit the Product Codes for Radiation-Emitting Electronic Products page.
How does FDA verify compliance with Radiation-Emitting Electronic Product Requirements?
FDA Entry Reviewers are trained to verify compliance with applicable product requirements. The FDA Entry Reviewers use the information provided to FDA in the importer’s entry transmission such as:
- Declared Manufacturer
- Product Description
- Affirmations of Compliance (A of C)
These entry declarations are compared to information in FDA’s internal data systems. If the information matches, then compliance is verified; if the information does not match, FDA may gather additional information or may detain the product.
The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that your shipment will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDA internal data systems.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
Are there additional requirements for medical radiation-emitting electronic products?
Radiation-emitting electronic products can be considered medical and non-medical products. In addition to the requirements above, radiation-emitting electronic medical products are also subject to medical device regulations. At the time of importation FDA will verify radiation-emitting electronic product requirements (medical and non-medical).
When do I have to submit Form FDA-2877?
Radiation-emitting electronic products subject to U.S. Federal Performance Standard require submission of Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, at the time of entry. Products not subject to federal performance standards do not require a Form FDA-2877 for importation into the US. At the time of importation FDA will verify the declarations submitted on Form FDA-2877.
There are four types of declarations on Form FDA-2877:
- Declaration A – Products that are not subject to radiation performance standards because they meet one of the seven statements.
- Declaration B – Products that must comply with Performance Standards.
- Declaration C – Products that do not comply with performance standards are being held under temporary import bond (TIB); will not be introduced into commerce; will be used under a radiation protection plan; and will be destroyed or exported under CBP supervision when the mission is complete.
- Declaration D - Products that do not comply with Performance Standards; are being held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that the products have been brought into compliance in accordance with an FDA approved petition.
For each declaration you must select a code which applies to your product. Refer to FDA Form 2877 Declaration Codes for more information.
Can I recondition non-compliant products?
The process of “reconditioning” non-compliant radiation-emitting electronic products may be difficult and time consuming which could result in the importer losing the product and money if the reconditioning is unsuccessful. The importer should make a serious effort to understand the FDA radiation safety requirements that are applicable to the products being imported. Reconditioning requests are submitted using the Form FDA-766.
Visit the reconditioning page for more information.
Affirmation of Compliance Codes for Radiation-Emitting Electronic Products
Affirmation of Compliance (A of C) codes are three letter codes that can be provided at the time of import to facilitate FDA review. FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements. Providing the correct A of C code reduces the likelihood that your shipment will be held for further FDA entry review during FDA’s import screening process. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.
For information on affirmation of compliance codes refer to the “Affirmation Of Compliance References” at the bottom of the affirmation of compliance codes page.
800-638-2041 301-847-8149 Fax DICE@fda.hhs.gov CDRH-Radiological Health Program Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue WO66-4613 Silver Spring, MD 20993
CDRH-Radiological Health Program
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue WO66-4613
Silver Spring, MD 20993