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  3. Electronic Product Radiation Control Program
  4. Getting a Radiation Emitting Product to Market
  5. Records and Reporting (Radiation-Emitting Products)
  6. Addresses for Electronic Product Radiation Control Reports and Recordkeeping
  1. Getting a Radiation Emitting Product to Market

Addresses for Electronic Product Radiation Control Reports and Recordkeeping

Addresses for Electronic Product Radiation Control Reports and Recordkeeping

Address all eSubmitter electronic submissions (on CD with signed Submittal letter) to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

You may also visit the FDA Electronic Submissions Gateway to establish a Gateway account so you may submit your eSubmitter documents via Internet:


All of the following documents:

  • Reports of Accidental Radiation Occurrences (AROs)
  • Notifications of radiation defect or failure to comply with a federal performance standard
  • Product reports, supplements, abbreviated reports, annual reports using the printed forms
  • Reports of Assembly using the printed form 2579
  • All other correspondence

Mail or ship to:

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

Reports and Recordkeeping


Address all variance requests to:

Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

See also Reports and Recordkeeping

Please note, you may also mail a copy of your variance to the CDRH address in Silver Spring, above; however, the Division of Dockets Management must receive the original signature. Variances may also be submitted electronically at www.regulations.gov via the shell Docket FDA-2013-S-0610.