2005 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	What does this part cover?
	803.3	How does FDA define the terms used in this part?
	803.9	What information from the reports do we disclose to the public?
	803.10	Generally, what are the reporting requirements that apply to me?
	803.11	What form should I use to submit reports of individual adverse events and where do I obtain these forms?
	803.12	Where and how do I submit reports and additional information?
	803.13	Do I need to submit reports in English?
	803.14	How do I submit a report electronically?
	803.15	How will I know if you require more information about my medical device report?
	803.16	When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
	803.17	What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
	803.18	What are the requirements for establishing and maintaining MDR files or records that apply to me?
	803.19	Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
	803.20	How do I complete and submit an individual adverse event report?
	803.21	Where can I find the reporting codes for adverse events that I use with medical device reports?
	803.22	What are the circumstances in which I am not required to file a report?
	803.30	If I am a user facility, what reporting requirements apply to me?
	803.32	If I am a user facility, what information must I submit in my individual adverse event reports?
	803.33	If I am a user facility, what must I include when I submit an annual report?
	803.40	If I am an importer, what kinds of individual adverse event reports must I submit, when must I submit them, and to whom must I submit them?
	803.42	If I am an importer, what information must I submit in my individual adverse event reports?
	803.50	If I am a manufacturer, what reporting requirements apply to me?
	803.52	If I am a manufacturer, what information must I submit in my individual adverse event reports?
	803.53	If I am a manufacturer, in which circumstances must I submit a 5-day report?
	803.55	If I am a manufacturer, in what circumstances must I submit a baseline report, and what are the requirements for such a report?
	803.56	If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
	803.58	Foreign manufacturers.