Chapter 22-B104 - MEDICAL DEVICE REPORTING

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