Submitting Reports and Requirements for Maintaining Records for Radiation
Policy on Imaging Systems During COVID-19
Please note that, for the duration of the COVID-19 public health emergency, the FDA does not intend to object to assemblers of diagnostic x-ray systems (as required by 21 CFR 1020.30(d)(1)) discontinuing the submission of Form 2579 Report of Assembly of a Diagnostic X-Ray System to the FDA. However, the FDA expects reports to be submitted to the purchaser and, where applicable, to the State agency responsible for radiation protection within 15 days following completion of the assembly pursuant to 21 CFR 1020.30(d)(1).
Questions on this policy can be sent to [email protected]. Additional information can be found in Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 2020).
- How to submit electronic product reports
- Reports of problems and hazards
- Required reports
- Variance applications
- Records to be maintained
How to submit electronic product reports:
Electronic Product Radiation Control (EPRC) Reports and Records may be submitted by any of the following methods:
Radiation Safety reports and correspondences are to be submitted to CDRH by email to [email protected]. This includes all report types, such as product reports, annual reports, supplemental reports, reports of accidental radiation occurrences (AROs) and, all communications (such as notifications of defect/failure to comply, corrective action plans, and AROs). Reports should be submitted in PDF format, or packaged by the eSubmitter packaging procedures, and attached to your email.
eSubmissions are no longer required to be transferred to a physical medium and mailed to the CDRH Document Control Center (DCC).
An eSubmitter user does not need to acquire an FDA Electronic Submissions Gateway account.
NOTE: [email protected] should not be used for submission of premarket approval applications (PMAs), premarket notifications [510(k)], or electronic medical device reporting (eMDR).
By postal mail:
Alternatively, electronic product radiation control reports and notifications may be submitted by postal mail 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
FDA eSubmitter Program:
The FDA eSubmitter program allows you to submit many Product Safety Reports and Annual Reports electronically. This free software is available for voluntary use by manufacturers in the Radiological Health industries. For more information about see FDA eSubmitter.
Reports of problems and hazards:
Manufacturers discovering a safety problem with their electronic products that is associated with radiation emission are required to notify FDA. Anyone discovering a safety problem can inform the FDA as well. The following list includes requirements and procedures for manufacturers to report a problem or hazard:
- Accidental Radiation Occurrences (21 CFR 1002.20)
- Notification Of Defects Or Failure To Comply (21 CFR 1003)
- Application for exemption from notification requirements (21 CFR 1003.30)
- Repurchase, Repairs, Or Replacements Of Electronic Products (21 CFR 1004)
Terms used in the radiological health regulations are defined under Title 21 Code of Federal Regulations Part 1000.3, Definitions (21 CFR 1000.3).
Additional information regarding submitting information associated with radiation concerns or illegal marketing of electronic products may be found on the following pages:
Manufacturers of electronic products may have certain reporting requirements, see Record and Reporting Requirements by Product (21 CFR 1002.1, Table 1) for the complete list. The following is a list of different types of required reports for electronic products:
- Records and Reports (21 CFR 1002)
- Reports Required Prior to Introduction of an Electronic Product which Emits Radiation into United States' Interstate Commerce
- Annual Reports (21 CFR 1002.13)
To find downloadable PDF forms and links to the eSubmitter software to create the reports identified above, view your specific product area. See the A-Z List of Regulated Products and Procedures. Each page has a section of information related to Industry Guidance.
Also, as noted in the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance document, 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.
In certain uncommon circumstances, a manufacturer may be granted an exemption from reporting. Please see the regulations referenced below.
- Exemptions from Reporting
- Compilation and Summary of Exemptions under the Radiological Health Program
In cases where manufacturers cannot comply with every requirement in the performance standard, they may apply for a variance from that requirement.
For more detailed information on how to submit a variance application using the updated process, please refer to the Electronic Product Radiation Control (EPRC) Variance Application Process webpage.
Records to be maintained:
Manufacturers of electronic products may have certain record-keeping requirements. The following list includes requirements and procedures for manufacturers to maintain records:
- Records to be maintained by manufacturers (21 CFR 1002.30)
- Preservation and inspection of records (21 CFR 1002.31)
- Records to be obtained by dealers and distributors (21 CFR 1002.40)