[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: 21CFR807.94]

[Page 71-72]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
              Subpart E--Premarket Notification Procedures
 
Sec. 807.94  Format of a class III certification.

    (a) A class III certification submitted as part of a premarket 
notification shall state as follows:

    I certify, in my capacity as (position held in company), of (company 
name), that I have

[[Page 72]]

conducted a reasonable search of all information known or otherwise 
available about the types and causes of safety or effectiveness problems 
that have been reported for the (type of device). I further certify that 
I am aware of the types of problems to which the (type of device) is 
susceptible and that, to the best of my knowledge, the following summary 
of the types and causes of safety or effectiveness problems about the 
(type of device) is complete and accurate.

    (b) The statement in paragraph (a) of this section should be signed 
by the certifier, clearly identified as ``class III certification,'' and 
included at the beginning of the section of the premarket notification 
submission that sets forth the class III summary.

[59 FR 64296, Dec. 14, 1994]