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Addresses for Electronic Product Radiation Control Reports and RecordkeepingAddress all CeSub electronic submissions (on CD with signed Submittal letter) to:
You may also contact to FDA Electronic Submissions Gateway to establish a Gateway account so you may submit your CeSub documents via Internet: Address all reports of accidental radiation occurrences to:
Address all reports of radiation defect or failure to comply with a federal performance standard to: Center for Devices and Radiological Health
Address all product, supplement, abbreviated, and annual reports using the printed reporting guides to: Center for Devices and Radiological Health Address all variance requests (Original with four copies) to: Food and Drug Administration For all other correspondence:
Updated June 20, 2008 |
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Center for Devices and Radiological Health / CDRH