[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1002.7]

[Page 601-602]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1002_RECORDS AND REPORTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 1002.7  Submission of data and reports.

    All submissions such as reports, test data, product descriptions, 
and other information required by this part, or voluntarily submitted to 
the Director, Center for Devices and Radiological Health, shall be filed 
with the number of copies as prescribed by the Director, Center for 
Devices and Radiological Health, and shall be signed by the person 
making the submission. The submissions required by this part shall be 
addressed to the Center for Devices and Radiological Health, ATTN: 
Electronic Product Reports, Radiological Health Document Control (HFZ-
309), Office of Communication, Education, and Radiation Programs, 9200 
Corporate Blvd., Rockville, MD 20850.
    (a) In addition to the requirements of this part, all material 
submitted to the Director, Center for Devices and Radiological Health, 
shall be submitted pursuant to the provisions of part 20--Public 
Information, of this chapter.
    (b) Where guides or instructions have been issued by the Director 
for the submission of material required by this part, such as test data, 
product reports, abbreviated reports, supplemental reports, and annual 
reports, the material submitted shall conform to the applicable 
reporting guides or instructions. Where it is not feasible or where it 
would not be appropriate to conform to any portion of a prescribed 
reporting

[[Page 602]]

guide or instruction, an alternate format for providing the information 
requested by that portion of the guide or instruction may be used 
provided the submitter of such information submits adequate explanation 
and justification for use of an alternate format. If the Director, 
Center for Devices and Radiological Health, determines that such 
justification is inadequate and that it is feasible or appropriate to 
conform to the prescribed reporting guide or instruction, he may require 
resubmission of the information in conformance with the reporting guide 
or instruction.
    (c) Where the submission of quality control and testing information 
is common to more than one model, or model family of the same product 
category, a ``common aspects report'' consolidating similar information 
may be provided, if applicable.

[42 FR 18062, Apr. 5, 1977, as amended at 53 FR 11254, Apr. 6, 1988; 60 
FR 48385, Sept. 19, 1995; 72 FR 17400, Apr. 9, 2007]