| 21:8.0.1.1.3.1 | SUBPART A
| Subpart A - General Provisions | |
| 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 | |
| 21:8.0.1.1.3.2 | SUBPART B
| Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports | |
| 21:8.0.1.1.3.2.1.1 | SECTION 803.20
| 803.20 How do I complete and submit an individual adverse event report | |
| 21:8.0.1.1.3.2.1.2 | SECTION 803.21
| 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports | |
| 21:8.0.1.1.3.2.1.3 | SECTION 803.22
| 803.22 What are the circumstances in which I am not required to file a report | |
| 21:8.0.1.1.3.2.1.4 | SECTION 803.23
| 803.23 Where can I find information on how to prepare and submit an MDR in electronic format | |
| 21:8.0.1.1.3.3 | SUBPART C
| Subpart C - User Facility Reporting Requirements | |
| 21:8.0.1.1.3.3.1.1 | SECTION 803.30
| 803.30 If I am a user facility, what reporting requirements apply to me | |
| 21:8.0.1.1.3.3.1.2 | SECTION 803.32
| 803.32 If I am a user facility, what information must I submit in my individual adverse event reports | |
| 21:8.0.1.1.3.3.1.3 | SECTION 803.33
| 803.33 If I am a user facility, what must I include when I submit an annual report | |
| 21:8.0.1.1.3.4 | SUBPART D
| Subpart D - Importer Reporting Requirements | |
| 21:8.0.1.1.3.4.1.1 | SECTION 803.40
| 803.40 If I am an importer, what reporting requirements apply to me | |
| 21:8.0.1.1.3.4.1.2 | SECTION 803.42
| 803.42 If I am an importer, what information must I submit in my individual adverse event reports | |
| 21:8.0.1.1.3.5 | SUBPART E
| Subpart E - Manufacturer Reporting Requirements | |
| 21:8.0.1.1.3.5.1.1 | SECTION 803.50
| 803.50 If I am a manufacturer, what reporting requirements apply to me | |
| 21:8.0.1.1.3.5.1.2 | SECTION 803.52
| 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports | |
| 21:8.0.1.1.3.5.1.3 | SECTION 803.53
| 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report | |
| 21:8.0.1.1.3.5.1.4 | SECTION 803.56
| 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 | |
| 21:8.0.1.1.3.5.1.5 | SECTION 803.58
| 803.58 Foreign manufacturers. | |