21 C.F.R. PART 803--MEDICAL DEVICE REPORTING


TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 803--MEDICAL DEVICE REPORTING

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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?
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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?
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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?
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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?
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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
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.
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