Chapter: 22-B104
MEDICAL DEVICE REPORTING 

Title: 22 HEALTH
SubTitle: 22-B PUBLIC HEALTH AND MEDICINE


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