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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 803MEDICAL DEVICE REPORTING
 

Subpart A--General Provisions
   § 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?

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?
   § 803.56 - 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

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