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  3. Electronic Product Radiation Control Program
  4. Getting a Radiation Emitting Product to Market: Frequently Asked Questions
  5. Radiation-Emitting Products Industry Assistance: Walk-through
  1. Getting a Radiation Emitting Product to Market: Frequently Asked Questions

Radiation-Emitting Products Industry Assistance: Walk-through

  • Introduction
  • Where to Start
  • Radiation-emitting products walkthrough
  • Requesting a variance or exemption from performance standards

    Introduction

    This page serves as a walkthrough and toolkit for all manufacturers of radiation-emitting products (all nonmedical and medical products) on industry guidance, policies, procedures, and reporting requirements. The FDA’s statutory authority to regulate radiation-emitting products is granted by the Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control.

    Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 through 1050 (21 CFR 1000 – 1050) contains radiation safety regulations for manufacturers of radiation-emitting electronic products. Manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation.

    Where to Start

    New manufacturers or importers
    Experienced manufacturers or importers of any radiation-emitting products

    Begin with Radiation-emitting products Walkthrough Section 3

    Radiation-emitting products Walkthrough

    1.  Determine if you are involved in manufacturing or importing radiation-emitting products or radiation-emitting medical devices (21 CFR §1000.3(n) & 21 CFR §1005.2)

    • If you are involved in manufacturing or importing radiation-emitting products, then you are subject to the requirements of 21 CFR 1000-1050. As a manufacturer or importer of regulated radiation-emitting electronic products, you have certain reporting and recordkeeping responsibilities.  (21 CFR 1002)
    • If you are a distributor of radiation-emitting products or radiation-emitting medical devices,
      you have certain recordkeeping responsibilities as required in  (21 CFR 1002.40)

    Generally speaking, if your firm is subject to 21 CFR 1000-1050, there are four steps you must follow prior to marketing your product in the United States.

    1. Design your product to comply with the applicable performance standard. This means that your product is designed so that it does not permit unnecessary exposure to radiation during use by complying with the requirements of the applicable performance standard.
    2. Good quality control during manufacturing to assure compliance to the applicable performance standard.  This means that your firm may sell your radiation-emitting product after (a) you have assured that your product is manufactured following an adequate quality control and testing program such that there is no unnecessary exposure to radiation during use and (b) the following two steps have been completed.
    3. Certification of each unit that it complies with the performance standard.  This means your firm is responsible for certifying that each unit complies with the applicable performance standard, and the units are labeled as such (21 CFR 1010).
    4. Submission of the applicable Product report to FDA to demonstrate that your product complies with the standard. This means that a Product report has been submitted to FDA/CDRH to demonstrate compliance to the applicable standard.  There are other reporting and record keeping requirements specified in 21 CFR 1002 – 1005 (see: Laws and Regulations (Radiation-Emitting Products)

    2. Determine if  your radiation-emitting product is also a medical device

    If your radiation-emitting product is also a medical device, it must comply with 2 independent sets of regulations.  It must comply with radiation safety regulations specified under  21 CFR 1000-1050 and described within these webpages.   It  must also comply with device regulations, which may include establishment registration, device listing, premarket notification and approval.  Please see  Is The Product A Medical Device and the Device Advice webpage  for more information.

    Firms that manufacture veterinary radiation-emitting devices need to comply with the radiological health regulations, administered by CDRH.  However, radiation-emitting devices intended for veterinary use only although considered medical devices as defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, are regulated by the Center for Veterinary Medicine,. Please note, that there is a labeling requirement (21 CFR 801.109) to restrict sale to veterinarians, as appropriate.

    Whether your radiation-emitting product is a medical device or not, proceed to Step 3 to determine the type of radiation-emitting product.

    3. Determine the type of radiation-emitting product

    Please refer to the hyperlink webpage, A-Z List of Regulated Products & Procedures, for a list of radiation-emitting products. Bookmark your product page and check back for new policies or guidance documents.  Updates can be effective immediately and require your attention.  There may be modifications to requirements that will be of interest to you.

    Please bookmark your product page and check back for new policies or guidance.  Updates can be effective immediately and require your attention.  There may be modifications or relaxations to requirements that will be of interest to you.

    3.1. Determine if products are subject to performance standards

    Review the applicability section of each performance standard to determine if your products are subject to the standard.  For specific summary of performance standards visit Summary Of The Electronic Product Radiation Control Provisions Of The Federal Food, Drug, And Cosmetic Act

    Radiation emitting products that are not covered by the performance standards listed in 21 CFR 1020-1050 are still subject to general requirements in the Title 21 CFR 1000-1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004.

    4. Determine Reporting Requirements

    To determine if your product is subject to any reporting requirements, view Table 1- Reporting and Recordkeeping Requirements by Product (21 CFR 1002.1, Table 1) and Subpart B- Required Manufacturers’ Reports for Listed Electronic Products, 21 CFR 1002.10-1002.13 for a descriptions of the reports.

    Please note that, for the duration of the COVID-19 public health emergency, FDA also does not object to the discontinuation of report submission by manufacturers of diagnostic x-ray products required by 21 CFR 1002 and identified in Table 1 of 21 CFR 1002.1.

    4.1 How to submit required reports

    All Radiation Safety reports may now be submitted to CDRH by email to the [email protected] mailbox.  This includes all report types, such as product reports, annual reports, and supplemental reports of all types, and all communications such as notifications of defect/failure to comply, corrective action plan (CAP) proposals, and accidental radiation occurrences (AROs).  Reports should be submitted in PDF format, or packaged by the eSubmitter packaging procedures, and attached to your email.  eSubmissions no longer need to be transferred to a physical medium and mailed to the CDRH Document Control Center.  An eSubmitter user does not need to acquire an FDA Electronic Submissions Gateway account. 

    NOTE: This Rad Health mailbox should not be used to submit Premarket device PMA or 510(k) documents or eMDR submissions.

    Reports concerning a radiation-emitting product or device can still be submitted by the three ways listed below:

    • 4.1.1: Electronic by Email
      • eSubmitter Software
      • PDF Forms
    • 4.1.2: Electronic through the FDA Gateway (eSubmitter)
    • 4.1.3: By Mail

    4.1.1 Electronic by Email

    eSubmitter software

    Preparing your submissions using the FDA eSubmitter electronic submissions software is the best way to prepare information for submission to FDA.

    Once the submission has been completed and packaged following the FDA eSubmitter instructions, you may email the report package (a ZIP file) and your signed submittal letter to the FDA email.  If the submission is a report, the files will be processed by our Document Control Center and you will receive an acknowledgement email within a few days giving you the FDA assigned Accession Number for the report.

    This option may be the best option when you have a need to submit a report immediately, but it doesn’t offer the fastest response for the acknowledgement email notice.  The FDA Gateway provides the fastest response (minutes instead of days). 

    Email your eSubmitter prepared report to [email protected]. PDF by Email

    Product reports may also be prepared using the fillable PDF reporting guide and emailed to [email protected].   These reports will be controlled by the Document Control Center and an acknowledgement letter will be emailed to the reporting official and the submitter within about 30 days

    The paper reporting guides are available and can be accessed on the individual electronic product-specific webpage found on the A-Z list under section 3 above.

    4.1.2 Electronic through the FDA Gateway

    Preparing the report for submission via the FDA Electronic Submissions Gateway is the same as preparing one to submit by email.  However, it is necessary to establish a WebTrader account with the FDA Gateway before you can submit through the Gateway.

    The FDA Electronic Submissions Gateway has its own separate web site where you can find information about the Gateway and the procedures for setting up an account.

    Of particular help are the links on the left side of the homepage to Center-Specific Submission Preparation Guidelines, Setting up a WebTrader Account Checklist, and the Tutorials link under Resources for You.

    Submissions made through the FDA Gateway are automatically routed to the proper Center for control by its Document Control Center.  Reports submitted to FDA for radiation-emitting products will typically be acknowledged by email within a few minutes or hours.

    4.1.3 By Mail

    Alternatively, electronic product radiation control reports may be prepared using the fillable PDF reporting guides and mailed to the following address:

    U.S. Food and Drug Administration
    Center for Devices and Radiological Health
    Document Control Center - WO66-G609
    10903 New Hampshire Avenue
    Silver Spring, MD 20993-0002

    5. Determine requirements for importing radiation-emitting electronic products:

    All imported radiation-emitting products must meet established standards and all products must contain informative and truthful labeling in English. 

    U.S Agent- Every manufacturer of electronic products, prior to offering such product for importation into the United States, shall designate a permanent resident of the United States as the manufacturer's agent upon whom service of all processes, notices, orders, decisions, and requirements may be made for and on behalf of the manufacturer. 21 CFR 1005.25 .

    6. Determine if there are any (or if you are aware of any) radiation safety concerns.

    Reporting of accidental radiation occurrences - 21 CFR 1002.20(a).When manufacturers of radiation-emitting electronic products become aware of an incident, they must immediately report accidental radiation occurrences (AROs) to CDRH following the instructions in 21 CFR 1002.20(a). The report may be submitted in the form of a letter, following the instructions in  21 CFR 1002.20(b).

    Also, both manufacturers and anyone in the general public may use the Accidental Radiation Occurrence Report fillable form to submit a report on any radiation incident or potentially hazardous event.

    ARO reports may be submitted to CDRH by email to the [email protected] mailbox

    Additional information regarding submitting information associated with radiation concerns or illegal marketing of electronic products may be found on the following pages:

    Also, manufacturers may use the FDA eSubmitter software to prepare and submit ARO reports and other correspondence electronically. You can download the FDA eSubmitter software and follow the instructions that accompany the software. More information on the FDA eSubmitter software can be found on the FDA web site.

    • Medical Device Adverse Event reports - 21 CFR 803

    If your radiation-emitting product is also a medical device, the MedWatch Medical Device Reporting (MDR) requirements supersede the ARO reporting requirements noted above. A manufacturer does not need to file both an ARO and MDR for the same adverse event.

    The MDR regulations require firms and other entities which become aware of deaths, serious injuries and in some cases, malfunctions associated with the medical devices, to notify the FDA using Form 3500A.  The MedWatch program also has provisions for voluntary reporting of a death, serious injury, or malfunction associated with a medical device by anyone who wishes to make FDA aware by using Form 3500.

    Requesting a Variance or Exemption from Performance Standards (21 CFR 1000-1050)

    If certain requirements are not appropriate or would cause the new product to not function as intended, manufacturers of products that are subject to performance standards in 21 CFR 1020-1050, may be granted variances or exemptions from these requirements under certain circumstances.

    1. Variances - For a product design which does not comply with a certain requirement of the applicable performance standard (See regulations and procedures in 21 CFR 1010.4)

    For additional information on how to submit a variance request, please review the Variance Application Process webpage.

    1. Exemptions from certain performance requirements for products intended for sale to Government agencies - For products developed under contract with the US Department of Defense or other federal agencies, see regulations and procedures at 21 CFR 1010.5 and Exemptions From Electronic Products Regulations.
    2. Exemptions from notification requirements - For products already in commercial distribution which are determined to exhibit a defect or failure to comply with an applicable regulatory requirement, but which can be shown not to create a significant risk of injury, including genetic injury, to any person, see regulations and procedures at 21 CFR 1003.30 and 21 CFR 1003.31.

    Questions may be directed to [email protected] or you may review the Radiation-Emitting Products web page.

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