[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: 21CFR895.22]

[Page 508-509]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 895--BANNED DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 895.22  Submission of data and information by the manufacturer, distributor, or importer.

    (a) A manufacturer, distributor, or importer of a device may be 
required to submit to the Food and Drug Administration all relevant and 
available data and information to enable the Commissioner to determine 
whether the device presents substantial deception, unreasonable and 
substantial risk of illness or injury, or unreasonable, direct, and 
substantial danger to the health of individuals. The data and 
information required by the Commissioner may include scientific or test 
data, reports, records, or other information, including data and 
information on whether the device is safe and effective for its intended 
use or when used as directed, whether the device performs according to 
the claims made for the device, and information on adulteration or 
misbranding. Any relevant information that is voluntarily submitted will 
also be reviewed.
    (b) A manufacturer, distributor, or importer of a device required to 
submit data and information as provided in paragraph (a) of this section 
will be notified in writing by the Food and Drug Administration that 
such data and information shall be submitted. The written notification 
will advise the manufacturer, distributor, or importer of the device 
that the purpose for the request is to enable the Commissioner to 
determine whether any of the conditions listed in paragraph (a) of this 
section or Sec. 895.30(a)(1) exists with respect to the device such that 
a proceeding should be initiated to make the device a banned device. 
When the required data and information can be identified by the Food and 
Drug Administration

[[Page 509]]

at the time of the notification, the agency will provide such 
identification to the manufacturer, distributor, or importer of the 
device.
    (c) The required data and information shall be submitted to the Food 
and Drug Administration no more than 30 days after the date of receipt 
of the request, unless the Commissioner determines that the data and 
information shall be submitted by some other date and so informs the 
manufacturer, distributor, or importer, in which case the data and 
information shall be submitted on the date specified by the 
Commissioner.
    (d) If the data or information submitted to the Food and Drug 
Administration is sufficient to persuade the Commissioner that the 
deception or risk of illness or injury or the danger to the health of 
individuals presented by a device could be corrected or eliminated by 
labeling or change in labeling, or change in advertising if the device 
is a restricted device, the Commissioner will proceed in accordance with 
Sec. 895.25.
    (e) If the data or information submitted to the Food and Drug 
Administration is insufficient to show that the device does not present 
a substantial deception or an unreasonable and substantial risk of 
illness or injury, or an unreasonable, direct, and substantial danger to 
the health of individuals, or if the manufacturer, distributor, or 
importer fails to submit the required information, the Commissioner may 
rely upon this insufficiency or failure to submit the required 
information in considering whether to initiate a proceeding to make the 
device a banned device under Sec. 895.21(d) and, when appropriate, to 
establish a special effective date in accordance with Sec. 895.30. The 
Commissioner may also initiate other regulatory action as provided in 
the act or this chapter.