[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: 21CFR807.87]

[Page 69-70]
 
                        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. 807.87  Information required in a premarket notification submission.

    Each premarket notification submission shall contain the following 
information:
    (a) The device name, including both the trade or proprietary name 
and the common or usual name or classification name of the device.
    (b) The establishment registration number, if applicable, of the 
owner or operator submitting the premarket notification submission.
    (c) The class in which the device has been put under section 513 of 
the act and, if known, its appropriate panel; or, if the owner or 
operator determines that the device has not been classified under such 
section, a statement of that determination and the basis for the 
person's determination that the device is not so classified.
    (d) Action taken by the person required to register to comply with 
the requirements of the act under section 514 for performance standards.
    (e) Proposed labels, labeling, and advertisements sufficient to 
describe the device, its intended use, and the directions for its use. 
Where applicable, photographs or engineering drawings should be 
supplied.
    (f) A statement indicating the device is similar to and/or different 
from other products of comparable type in commercial distribution, 
accompanied by data to support the statement. This information may 
include an identification of similar products, materials, design 
considerations, energy expected to be used or delivered by the device, 
and a description of the operational principles of the device.
    (g) Where a person required to register intends to introduce into 
commercial distribution a device that has undergone a significant change 
or modification that could significantly affect the safety or 
effectiveness of the device, or the device is to be marketed for a new 
or different indication for use, the premarket notification submission 
must include appropriate supporting data to show that the manufacturer 
has considered what consequences and effects the change or modification 
or new use might have on the safety and effectiveness of the device.
    (h) A 510(k) summary as described in Sec. 807.92 or a 510(k) 
statement as described in Sec. 807.93.
    (i) A financial certification or disclosure statement or both, as 
required by part 54 of this chapter.
    (j) For submissions claiming substantial equivalence to a device 
which has been classified into class III under section 513(b) of the 
act:
    (1) Which was introduced or delivered for introduction into 
interstate commerce for commercial distribution before December 1, 1990; 
and
    (2) For which no final regulation requiring premarket approval has 
been issued under section 515(b) of the act, a summary of the types of 
safety and effectiveness problems associated with the type of devices 
being compared and a citation to the information upon which the summary 
is based (class III summary). The 510(k) submitter shall also certify 
that a reasonable search of all information known or otherwise available 
about the class III device and other similar legally marketed devices 
has been conducted (class III certification), as described in 
Sec. 807.94. This information does not refer to information that already 
has been submitted to the Food and Drug Administration (FDA) under 
section 519 of the act. FDA may require the submission of the adverse 
safety and effectiveness data described in the class III summary or 
citation.
    (k) A statement that the submitter believes, to the best of his or 
her knowledge, that all data and information submitted in the premarket 
notification are truthful and accurate and that no material fact has 
been omitted.
    (l) Any additional information regarding the device requested by the 
Commissioner that is necessary for the Commissioner to make a finding as 
to whether or not the device is substantially equivalent to a device in 
commercial distribution. A request for additional information will 
advise the owner or operator that there is insufficient information 
contained in the original premarket notification submission for the 
Commissioner to make this determination and that the owner

[[Page 70]]

or operator may either submit the requested data or a new premarket 
notification containing the requested information at least 90 days 
before the owner or operator intends to market the device, or submit a 
premarket approval application in accordance with section 515 of the 
act. If the additional information is not submitted within 30 days 
following the date of the request, the Commissioner will consider the 
premarket notification to be withdrawn.

(Information collection requirements in this section were approved by 
the Office of Management and Budget (OMB) and assigned OMB control 
number 0910-0281)

[42 FR 42526, Aug 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59 
FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998]