[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: 21CFR803.53]



[Page 54]

 

                        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 E_Manufacturer Reporting Requirements

 

Sec.  803.53  If I am a manufacturer, in which circumstances must I 

submit a 5-day report?



    You must submit a 5-day report to us, on Form 3500A or an electronic 

equivalent approved under Sec.  803.14, no later than 5 work days after 

the day that you become aware that:

    (a) An MDR reportable event necessitates remedial action to prevent 

an unreasonable risk of substantial harm to the public health. You may 

become aware of the need for remedial action from any information, 

including any trend analysis; or

    (b) We have made a written request for the submission of a 5-day 

report. If you receive such a written request from us, you must submit, 

without further requests, a 5-day report for all subsequent events of 

the same nature that involve substantially similar devices for the time 

period specified in the written request. We may extend the time period 

stated in the original written request if we determine it is in the 

interest of the public health.