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Reports and Recordkeeping

Reports of problems and hazards:

CeSub Electronic Submission Program:

The CeSub Electronic submission program allows you to submit many Product Safety Reports and Annual Reports electronically. This new software tool is called CeSub eSubmitter. This free software is available for voluntary use by sponsors and manufacturers in the device and Radiological Health industries. For more information about CeSub, see CeSub Electronic Submission Program.

Required reports:

Variance requests:

Records to be maintained:

Addresses:

Updated December 29, 2006

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