Home
gpo.gov
govinfo.gov
e-CFR Navigation Aids
Browse
Simple Search
Advanced Search
— Boolean
— Proximity
Search History
Search Tips
Corrections
Latest Updates
User Info
FAQs
Agency List
Incorporation By Reference
Related Resources
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.
Download the Code of Federal Regulations in XML.
Download the Electronic Code of Federal Regulations in XML.
Monthly Title and Part user viewing data for the e-CFR is available for download in CSV format.
Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code Text | PDF
Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.
Purchase individual CFR titles from the U.S. Government Online Bookstore.
Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.
[A2]
|
|
Electronic Code of Federal Regulations
| e-CFR data is current as of December 3, 2019
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER H—MEDICAL DEVICES PART 803—MEDICAL DEVICE REPORTING
Subpart A—GENERAL PROVISIONS
|
What does this part cover? |
|
|
How does FDA define the terms used in this part? |
|
|
What information from the reports do we disclose to the public? |
|
|
Generally, what are the reporting requirements that apply to me? |
|
|
What form should I use to submit reports of individual adverse events and where do I obtain these forms? |
|
|
How do I submit initial and supplemental or followup reports? |
|
|
Do I need to submit reports in English? |
|
|
How will I know if you require more information about my medical device report? |
|
|
When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? |
|
|
What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? |
|
|
What are the requirements for establishing and maintaining MDR files or records that apply to me? |
|
|
Are there exemptions, variances, or alternative forms of adverse event reporting requirements? |
|
Subpart B—GENERALLY APPLICABLE REQUIREMENTS FOR INDIVIDUAL ADVERSE EVENT REPORTS
|
How do I complete and submit an individual adverse event report? |
|
|
Where can I find the reporting codes for adverse events that I use with medical device reports? |
|
|
What are the circumstances in which I am not required to file a report? |
|
|
Where can I find information on how to prepare and submit an MDR in electronic format? |
|
Subpart C—USER FACILITY REPORTING REQUIREMENTS
|
If I am a user facility, what reporting requirements apply to me? |
|
|
If I am a user facility, what information must I submit in my individual adverse event reports? |
|
|
If I am a user facility, what must I include when I submit an annual report? |
|
Subpart D—IMPORTER REPORTING REQUIREMENTS
|
If I am an importer, what reporting requirements apply to me? |
|
|
If I am an importer, what information must I submit in my individual adverse event reports? |
|
Subpart E—MANUFACTURER REPORTING REQUIREMENTS
|
If I am a manufacturer, what reporting requirements apply to me? |
|
|
If I am a manufacturer, what information must I submit in my individual adverse event reports? |
|
|
If I am a manufacturer, in which circumstances must I submit a 5-day report? |
|
|
If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports? |
|
|
|