[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.56]

[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. 803.56  Supplemental reports.

    When a manufacturer obtains information required under this part 
that was not provided because it was not known or was not available when 
the initial report was submitted, the manufacturer shall submit to FDA 
the supplemental information within 1 month following receipt of such 
information. In supplemental reports, the manufacturer shall:
    (a) Indicate on the form and the envelope, that the reporting form 
being submitted is a supplemental report. If the report being 
supplemented is an FDA Form 3500A report, the manufacturer must select, 
in Item H-2, the appropriate code for the type of supplemental 
information being submitted;
    (b) Provide the appropriate identification numbers of the report 
that will be updated with the supplemental information, e.g., original 
manufacturer report number and user facility report number, if 
applicable;
    (c) For reports that cross reference previous reports, include only 
the new, changed, or corrected information in the appropriate portion(s) 
of the respective form(s).