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:

• FDA eSubmitter Instructions
• Electronic Submissions Gateway

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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

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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.