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
• eSubmitter Gateway

 Address all reports of accidental radiation occurrences 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

See also Reports and Recordkeeping

 Address all reports of radiation defect or failure to comply with a federal performance standard 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

See also Reports and Recordkeeping

 Address all product, supplement, abbreviated, and annual reports using the printed reporting guides 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

See also Reports and Recordkeeping

 Address all variance requests (Original with two copies) to:

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

See also Reports and Recordkeeping

For all other correspondence:

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