[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.17]

[Page 50]
 
                        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  What are the requirements for developing, maintaining, and 

implementing written MDR procedures that apply to me?

    If you are a user facility, importer, or manufacturer, you must 
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 MDR requirements;
    (2) A standardized review process or procedure for determining when 
an event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to 
manufacturers or to us, or to both if required.
    (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 
manufacturers and/or us;
    (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 us.