About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  

The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

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.

[1]
 
 

Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of October 22, 2014

Title 21Chapter ISubchapter HPart 803


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

rule

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?
rule

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?
rule

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?
rule

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?
rule

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.


For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.
For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.