[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: 21CFR803.56]

[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.  803.56  If I am a manufacturer, in what circumstances must I submit a 

supplemental or followup report and what are the requirements for such 

reports?

    If you are a manufacturer, when you obtain information required 
under this part that you did not provide because it was not known or was 
not available when you submitted the initial report, you must submit the 
supplemental information to us within 1 month of the day that you 
receive this information. On a supplemental or followup report, you 
must:
    (a) Indicate on the envelope and in the report that the report being 
submitted is a supplemental or followup report. If you are using FDA 
form 3500A, indicate this in Block Item H-2;
    (b) Submit the appropriate identification numbers of the report that 
you are updating with the supplemental information (e.g., your original 
manufacturer report number and the user facility or importer report 
number of any report on which your report was based), if applicable; and
    (c) Include only the new, changed, or corrected information in the 
appropriate portion(s) of the respective form(s) for reports that cross 
reference previous reports.