[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.18]

[Page 51-52]
 
                        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. 803.18  What are the requirements for establishing and 
maintaining MDR files or records that apply to me?

    (a) If you are a user facility, importer, or manufacturer, you must 
establish and maintain MDR event files. You must clearly identify all 
MDR event files and maintain them to facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written or 
electronic files maintained by user facilities, importers, and 
manufacturers. MDR event files may incorporate references to other 
information (e.g.,

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medical records, patient files, engineering reports), in lieu of copying 
and maintaining duplicates in this file. Your MDR event files must 
contain:
    (i) Information in your possession or references to information 
related to the adverse event, including all documentation of your 
deliberations and decisionmaking processes used to determine if a 
device-related death, serious injury, or malfunction was or was not 
reportable under this part; and
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that you submitted to us and other 
entities such as an importer, distributor, or manufacturer.
    (2) If you are a user facility, importer, or manufacturer, you must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (c) If you are a user facility, you must retain an MDR event file 
relating to an adverse event for a period of 2 years from the date of 
the event. If you are a manufacturer or importer, you must retain an MDR 
event file relating to an adverse event for a period of 2 years from the 
date of the event or a period of time equivalent to the expected life of 
the device, whichever is greater. If the device is no longer 
distributed, you still must maintain MDR event files for the time 
periods described in this paragraph.
    (d)(1) If you are a device distributor, you must establish and 
maintain device complaint records (files). Your records must contain any 
incident information, including any written, electronic, or oral 
communication, either received or generated by you, that alleges 
deficiencies related to the identity (e.g., labeling), quality, 
durability, reliability, safety, effectiveness, or performance of a 
device. You must also maintain information about your evaluation of the 
allegations, if any, in the incident record. You must clearly identify 
the records as device incident records and file these records by device 
name. You may maintain these records in written or electronic format. 
You must back up any file maintained in electronic format.
    (2) You must retain copies of the required device incident records 
for a period of 2 years from the date of inclusion of the record in the 
file or for a period of time equivalent to the expected life of the 
device, whichever is greater. You must maintain copies of these records 
for this period even if you no longer distribute the device.
    (3) You must maintain the device complaint files established under 
this section at your principal business establishment. If you are also a 
manufacturer, you may maintain the file at the same location as you 
maintain your complaint file under part 820 of this chapter. You must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (e) If you are a manufacturer, you may maintain MDR event files as 
part of your complaint file, under part 820 of this chapter, if you 
prominently identify these records as MDR reportable events. We will not 
consider your submitted MDR report to comply with this part unless you 
evaluate an event in accordance with the quality system requirements 
described in part 820 of this chapter. You must document and maintain in 
your MDR event files an explanation of why you did not submit or could 
not obtain any information required by this part, as well as the results 
of your evaluation of each event.