[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
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  Files and distributor records.

    (a) User facilities, importers, and manufacturers shall establish 
and maintain MDR event files. All MDR event files shall be prominently 
identified as such and filed 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., medical records, patient files, engineering reports, 
etc., in lieu of copying and maintaining duplicates in this file. MDR 
event files must contain:
    (i) Information in the possession of the reporting entity or 
references to information related to the adverse event, including all 
documentation of the entity's deliberations and decisionmaking processes 
used to determine if a device-related death, serious injury, or 
malfunction was or was not reportable under this part.
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that was submitted to FDA and other 
entities (e.g., an importer, distributor, or manufacturer).
    (2) User facilities, importers, and manufacturers shall permit any 
authorized FDA employee during all reasonable times to access, to copy, 
and to verify the records required by this part.
    (c) User facilities shall retain an MDR event file relating to an 
adverse event for a period of 2 years from the date of the event. 
Manufacturers and

[[Page 46]]

importers shall 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. MDR 
event files must be maintained for the time periods described in this 
paragraph even if the device is no longer distributed.
    (d)(1) A device distributor shall establish and maintain device 
complaint records containing any incident information, including any 
written, electronic, or oral communication, either received by or 
generated by the firm, that alleges deficiencies related to the identity 
(e.g., labeling), quality, durability, reliability, safety, 
effectiveness, or performance of a device. Information regarding the 
evaluation of the allegations, if any, shall also be maintained in the 
incident record. Device incident records shall be prominently identified 
as such and shall be filed by device, and may be maintained in written 
or electronic form. Files maintained in electronic form must be backed 
up.
    (2) A device distributor shall retain copies of the records required 
to be maintained under this section 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, 
even if the distributor has ceased to distribute the device that is the 
subject of the record.
    (3) A device distributor shall maintain the device complaint files 
established under this section at the distributor's principal business 
establishment. A distributor that is also a manufacturer may maintain 
the file at the same location as the manufacturer maintains its 
complaint file under Secs. 820.180 and 820.198 of this chapter. A device 
distributor shall permit any authorized FDA employee, during all 
reasonable times, to have access to, and to copy and verify, the records 
required by this part.
    (e) The manufacturer may maintain MDR event files as part of its 
complaint file, under Sec. 820.198 of this chapter, provided that such 
records are prominently identified as MDR reportable events. A report 
submitted under this subpart A shall not be considered to comply with 
this part unless the event has been evaluated in accordance with the 
requirements of Secs. 820.162 and 820.198 of this chapter. MDR files 
shall contain an explanation of why any information required by this 
part was not submitted or could not be obtained. The results of the 
evaluation of each event are to be documented and maintained in the 
manufacturer's MDR event file.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]