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22-B10400
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GENERAL
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7/12/2013
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22-B10401
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PUBLIC AVAILABILITY OF REPORTS
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7/12/2013
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22-B10402
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GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS
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7/12/2013
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22-B10403
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RESERVED
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7/12/2013
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22-B10404
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WHERE TO SUBMIT REPORTS
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7/12/2013
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22-B10405
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ENGLISH REPORTING REQUIREMENT
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7/12/2013
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22-B10406
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ELECTRONIC REPORTING
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7/12/2013
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22-B10407
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REQUESTS FOR ADDITIONAL INFORMATION
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7/12/2013
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22-B10408
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DISCLAIMERS
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7/12/2013
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22-B10409
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WRITTEN MEDICAL DEVICE REPORT PROCEDURES
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7/12/2013
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22-B10410
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FILES AND DISTRIBUTOR RECORDS
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7/12/2013
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22-B10411
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EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS
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7/12/2013
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22-B10412
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HOW TO REPORT ADVERSE EVENTS
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7/12/2013
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22-B10413
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WHERE TO FIND REPORTING CODES USED WITH MEDICAL DEVICE REPORTS
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7/12/2013
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22-B10414
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WHEN NOT TO FILE A REPORT
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7/12/2013
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22-B10415
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INDIVIDUAL ADVERSE EVENT REPORTS: USER FACILITIES
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7/12/2013
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22-B10416
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INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES
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7/12/2013
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22-B10417
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ANNUAL REPORTS
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7/12/2013
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22-B10418
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INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS
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7/12/2013
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22-B10419
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INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS
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7/12/2013
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22-B10420
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INDIVIDUAL ADVERSE EVENT REPORTS REQUIREMENTS FOR MANUFACTURERS
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7/12/2013
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22-B10421
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INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR MANUFACTURERS
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7/12/2013
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22-B10422
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FIVE (5) - DAY REPORTS FOR MANUFACTURERS
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7/12/2013
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22-B10423
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SUPPLEMENTAL REPORTS
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7/12/2013
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22-B10424
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FOREIGN MANUFACTURERS
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7/12/2013
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22-B10499
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DEFINITIONS
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4/6/2018
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