[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.53]

[Page 53]
 
                        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  Five-day reports.

    A manufacturer shall submit a 5-day report to FDA, on Form 3500A or 
electronic equivalent as approved by FDA under Sec. 803.14 within 5 
workdays of:
    (a) Becoming aware that a reportable MDR event or events, from any 
information, including any trend analysis, necessitates remedial action 
to prevent an unreasonable risk of substantial harm to the public 
health; or
    (b) Becoming aware of an MDR reportable event for which FDA has made 
a written request for the submission of a 5-day report. When such a 
request is made, the manufacturer shall 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. The time period stated in the original written 
request can be extended by FDA if it is in the interest of the public 
health.