[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.18]



[Page 45-46]

 

                        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.,



[[Page 46]]



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.