[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: 21CFR803.14]

[Page 44]
 
                        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  Electronic reporting.

    (a) Any report required by this part may be submitted electronically 
with prior written consent from FDA. Such consent is revocable. 
Electronic report submissions include alternative reporting media 
(magnetic tape, disc, etc.) and computer-to-computer communication.
    (b) Any electronic report meeting electronic reporting standards, 
guidance documents, or other procedures developed by the agency for MDR 
reporting will be deemed to have prior approval for use.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 56480, Sept. 19, 2000]