Title 21

PART 803 SUBPART A

21:8.0.1.1.3.1.1.1	SECTION 803.1	803.1 What does this part cover
21:8.0.1.1.3.1.1.2	SECTION 803.3	803.3 How does FDA define the terms used in this part
21:8.0.1.1.3.1.1.3	SECTION 803.9	803.9 What information from the reports do we disclose to the public
21:8.0.1.1.3.1.1.4	SECTION 803.10	803.10 Generally, what are the reporting requirements that apply to me
21:8.0.1.1.3.1.1.5	SECTION 803.11	803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms
21:8.0.1.1.3.1.1.6	SECTION 803.12	803.12 How do I submit initial and supplemental or followup reports
21:8.0.1.1.3.1.1.7	SECTION 803.13	803.13 Do I need to submit reports in English
21:8.0.1.1.3.1.1.8	SECTION 803.15	803.15 How will I know if you require more information about my medical device report
21:8.0.1.1.3.1.1.9	SECTION 803.16	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
21:8.0.1.1.3.1.1.10	SECTION 803.17	803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me
21:8.0.1.1.3.1.1.11	SECTION 803.18	803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me
21:8.0.1.1.3.1.1.12	SECTION 803.19	803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements