[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.17]

[Page 45]
 
                        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. 803.17  Written MDR procedures.

    User facilities, importers, and manufacturers shall develop, 
maintain, and implement written MDR procedures for the following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and 
evaluation of events that may be subject to medical device reporting 
requirements;
    (2) A standardized review process/procedure for determining when an 
event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to FDA 
and/or manufacturers;
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was 
reportable;
    (2) All medical device reports and information submitted to FDA and 
manufacturers;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of annual reports; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by FDA.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000; 66 
FR 23157, May 8, 2001]