Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 803--MEDICAL DEVICE REPORTING

TEXT PDF803.1 Scope.
TEXT PDF803.3 Definitions.
TEXT PDF803.9 Public availability of reports.
TEXT PDF803.10 General description of reports required from user facilities and manufacturers.
TEXT PDF803.11 Obtaining the forms.
TEXT PDF803.12 Where to submit reports.
TEXT PDF803.13 English reporting requirement.
TEXT PDF803.14 Electronic reporting.
TEXT PDF803.15 Requests for additional information.
TEXT PDF803.16 Disclaimers.
TEXT PDF803.17 Written MDR procedures.
TEXT PDF803.18 Files.
TEXT PDF803.19 Exemptions, variances, and alternative reporting requirements.
TEXT PDF803.20 How to report.
TEXT PDF803.21 Reporting codes.
TEXT PDF803.22 When not to file.
TEXT PDF803.30 Individual adverse event reports; user facilities.
TEXT PDF803.32 Individual adverse event report data elements.
TEXT PDF803.33 Semiannual reports.
TEXT PDF803.50 Individual adverse event reports; manufacturers.
TEXT PDF803.52 Individual adverse event report data elements.
TEXT PDF803.53 Five-day reports.
TEXT PDF803.55 Baseline reports.
TEXT PDF803.56 Supplemental reports.
TEXT PDF803.57 Annual certification.
TEXT PDF803.58 Foreign manufacturers.

--------------------------------------------------------------------- -----------

[BACK ][BACK ]