[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: 21CFR803.17]



[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  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.