[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.93]

[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. 807.93  Content and format of a 510(k) statement.

    (a)(1) A 510(k) statement submitted as part of a premarket 
notification shall state as follows:

    I certify that, in my capacity as (the position held in company by 
person required to submit the premarket notification, preferably the 
official correspondent in the firm), of (company name), I will make 
available all information included in this premarket notification on 
safety and effectiveness within 30 days of request by any person if the 
device described in the premarket notification submission is determined 
to be substantially equivalent. The information I agree to make 
available will be a duplicate of the premarket notification submission, 
including any adverse safety and effectiveness information, but 
excluding all patient identifiers, and trade secret and confidential 
commercial information, as defined in 21 CFR 20.61.

    (2) The statement in paragraph (a)(1) of this section should be 
signed by the certifier, made on a separate page of the premarket 
notification submission, and clearly identified as ``510(k) statement.''
    (b) All requests for information included in paragraph (a) of this 
section shall be made in writing to the certifier, whose name will be 
published by FDA on the list of premarket notification submissions for 
which substantial equivalence determinations have been made.
    (c) The information provided to requestors will be a duplicate of 
the premarket notification submission, including any adverse 
information, but excluding all patient identifiers, and

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trade secret and confidential commercial information as defined in 
Sec. 20.61 of this chapter.

[59 FR 64295, Dec. 14, 1994]