[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: 21CFR803.56]



[Page 55]

 

                        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.