[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR803.1] [Page 38-39] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 803_MEDICAL DEVICE REPORTING--Table of Contents Subpart A_General Provisions Sec. 803.1 What does this part cover? Subpart A_General Provisions Sec. 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? Subpart B_Generally Applicable Requirements for Individual Adverse Event Reports 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? Subpart C_User Facility Reporting Requirements 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? [[Page 39]] Subpart D_Importer Reporting Requirements 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? Subpart E_Manufacturer Reporting Requirements 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 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. Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374. Source: 70 FR 9519, July 13, 2005, unless otherwise noted (a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified followup and baseline reports. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents. (b) This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.