2001 CFR Title 21, Volume 8

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 803--MEDICAL DEVICE REPORTING
	803.1	Scope.
	803.3	Definitions.
	803.9	Public availability of reports.
	803.10	General description of reports required from user facilities, importers, and manufacturers.
	803.11	Obtaining the forms.
	803.12	Where to submit reports.
	803.13	English reporting requirement.
	803.14	Electronic reporting.
	803.15	Requests for additional information.
	803.16	Disclaimers.
	803.17	Written MDR procedures.
	803.18	Files and distributor records.
	803.19	Exemptions, variances, and alternative reporting requirements.
	803.20	How to report.
	803.21	Reporting codes.
	803.22	When not to file.
	803.30	Individual adverse event reports; user facilities.
	803.32	Individual adverse event report data elements.
	803.33	Annual reports.
	803.40	Individual adverse event reporting requirements; importers.
	803.42	Individual adverse event report data elements.
	803.50	Individual adverse event reports; manufacturers.
	803.52	Individual adverse event report data elements.
	803.53	Five-day reports.
	803.55	Baseline reports.
	803.56	Supplemental reports.
	803.58	Foreign manufacturers.