[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.53]

[Page 60]
 
                        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.