D.C. Mun. Regs. tit. 22-B, ch. 104 – Medical Device Reporting | Midpage

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District of Columbia Municipal Regulations

Chapter 22-B104

D.C. Mun. Regs. tit. 22-B, ch. 104

Medical Device Reporting

District of Columbia, Office of the Secretary

22-B10400General 22-B10401Public Availability of Reports 22-B10402General Description of Reports Required From User Facilities, Importers, and Manufacturers 22-B10403Reserved 22-B10404Where to Submit Reports 22-B10405English Reporting Requirement 22-B10406Electronic Reporting 22-B10407Requests for Additional Information 22-B10408Disclaimers 22-B10409Written Medical Device Report Procedures 22-B10410Files and Distributor Records 22-B10411Exemptions, Variances, and Alternative Reporting Requirements 22-B10412How to Report Adverse Events 22-B10413Where to Find Reporting Codes Used with Medical Device Reports 22-B10414When Not to File a Report 22-B10415Individual Adverse Event Reports: User Facilities 22-B10416Individual Adverse Event Report Data Elements for User Facilities 22-B10417Annual Reports 22-B10418Individual Adverse Event Reporting Requirements for Importers 22-B10419Individual Adverse Event Report Data Elements for Importers 22-B10420Individual Adverse Event Reports Requirements for Manufacturers 22-B10421Individual Adverse Event Report Data Elements for Manufacturers 22-B10422Five (5) - Day Reports for Manufacturers 22-B10423Supplemental Reports 22-B10424Foreign Manufacturers 22-B10499Definitions