[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: 21CFR803.14]

[Page 50]
 
                        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 A_General Provisions
 
Sec.  803.14  How do I submit a report electronically?

    (a) You may electronically submit any report required by this part 
if you have our prior written consent. We may revoke this consent at 
anytime. Electronic report submissions include alternative reporting 
media (magnetic tape, disc, etc.) and computer-to-computer 
communication.
    (b) If your electronic report meets electronic reporting standards, 
guidance documents, or other MDR reporting procedures that we have 
developed, you may submit the report electronically without receiving 
our prior written consent.