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FDA > CDRH > Radiological Health Program > Regulated Industry > Reporting > Addresses for Electronic Product Radiation Control Reports and Recordkeeping

Addresses for Electronic Product Radiation Control Reports and Recordkeeping

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

Electronic Product Document Control (HFZ-309)
Attn: CeSub Team
Center for Devices and Radiological Health
2094 Gaither Road
Rockville, MD 20850

You may also contact to FDA Electronic Submissions Gateway to establish a Gateway account so you may submit your CeSub documents via Internet:

www.fda.gov/esg

Address all reports of accidental radiation occurrences to:

Center for Devices and Radiological Health
ATTN: Accidental Radiation Occurrence Reports (HFZ-240)
Office of Communication, Education, and Radiation Programs
9200 Corporate Boulevard
Rockville, MD 20850

See also Reports and Recordkeeping

Address all reports of radiation defect or failure to comply with a federal performance standard to:
Center for Devices and Radiological Health
ATTN: Notice of Defect or Noncompliance (HFZ-240)
Office of Communication, Education, and Radiation Programs
9200 Corporate Boulevard
Rockville, MD 20850

See also Reports and Recordkeeping

Address all product, supplement, abbreviated, and annual reports using the printed reporting guides to:
Center for Devices and Radiological Health
ATTN: Electronic Product Reports
Radiological Health Document Control (HFZ-309)
Office of Communication, Education, and Radiation Programs
9200 Corporate Blvd
Rockville, MD 20850

See also Reports and Recordkeeping

Address all variance requests (Original with four 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:

Center for Devices and Radiological Health
ATTN: Office of Communication, Education, and Radiation Programs (HFZ-240)
9200 Corporate Boulevard
Rockville, MD 20850
240-276-3332
FAX: 240-276-3272

Updated June 20, 2008

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