[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: 21CFR807.92]

[Page 70-71]
 
                        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. 807.92  Content and format of a 510(k) summary.

    (a) A 510(k) summary shall be in sufficient detail to provide an 
understanding of the basis for a determination of substantial 
equivalence. FDA will accept summaries as well as amendments thereto 
until such time as FDA issues a determination of substantial 
equivalence. All 510(k) summaries shall contain the following 
information:
    (1) The submitter's name, address, telephone number, a contact 
person, and the date the summary was prepared;
    (2) The name of the device, including the trade or proprietary name 
if applicable, the common or usual name, and the classification name, if 
known;
    (3) An identification of the legally marketed device to which the 
submitter claims equivalence. A legally marketed device to which a new 
device may be compared for a determination regarding substantial 
equivalence is a device that was legally marketed prior to May 28, 1976, 
or a device which has been reclassified from class III to class II or I 
(the predicate), or a device which has been found to be substantially 
equivalent through the 510(k) premarket notification process;
    (4) A description of the device that is the subject of the premarket 
notification submission, such as might be found in the labeling or 
promotional material for the device, including an explanation of how the 
device functions, the scientific concepts that form the basis for the 
device, and the significant physical and performance characteristics of 
the device, such as device design, material used, and physical 
properties;
    (5) A statement of the intended use of the device that is the 
subject of the premarket notification submission, including a general 
description of the diseases or conditions that the device will diagnose, 
treat, prevent, cure, or mitigate, including a description,

[[Page 71]]

where appropriate, of the patient population for which the device is 
intended. If the indication statements are different from those of the 
legally marketed device identified in paragraph (a)(3) of this section, 
the 510(k) summary shall contain an explanation as to why the 
differences are not critical to the intended therapeutic, diagnostic, 
prosthetic, or surgical use of the device, and why the differences do 
not affect the safety and effectiveness of the device when used as 
labeled; and
    (6) If the device has the same technological characteristics (i.e., 
design, material, chemical composition, energy source) as the predicate 
device identified in paragraph (a)(3) of this section, a summary of the 
technological characteristics of the new device in comparison to those 
of the predicate device. If the device has different technological 
characteristics from the predicate device, a summary of how the 
technological characteristics of the device compare to a legally 
marketed device identified in paragraph (a)(3) of this section.
    (b) 510(k) summaries for those premarket submissions in which a 
determination of substantial equivalence is also based on an assessment 
of performance data shall contain the following information:
    (1) A brief discussion of the nonclinical tests submitted, 
referenced, or relied on in the premarket notification submission for a 
determination of substantial equivalence;
    (2) A brief discussion of the clinical tests submitted, referenced, 
or relied on in the premarket notification submission for a 
determination of substantial equivalence. This discussion shall include, 
where applicable, a description of the subjects upon whom the device was 
tested, a discussion of the safety or effectiveness data obtained from 
the testing, with specific reference to adverse effects and 
complications, and any other information from the clinical testing 
relevant to a determination of substantial equivalence; and
    (3) The conclusions drawn from the nonclinical and clinical tests 
that demonstrate that the device is as safe, as effective, and performs 
as well as or better than the legally marketed device identified in 
paragraph (a)(3) of this section.
    (c) The summary should be in a separate section of the submission, 
beginning on a new page and ending on a page not shared with any other 
section of the premarket notification submission, and should be clearly 
identified as a ``510(k) summary.''
    (d) Any other information reasonably deemed necessary by the agency.

[57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994]