[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: 21CFR803.14]



[Page 45]

 

                        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.