[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: 21CFR807.37]

[Page 72-73]
 
                        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 B_Procedures for Device Establishments
 
Sec. 807.37  Inspection of establishment registration and device listings.

    (a) A copy of the forms FDA-2891 and FDA-2891a filed by the 
registrant will be available for inspection in accordance with section 
510(f) of the act, at the Center for Devices and Radiological Health 
(HFZ-308), Food and Drug Administration, Department of Health and Human 
Services, 9200 Corporate Blvd., Rockville, MD 20850-4015. In addition, 
there will be available for inspection at each of the Food and Drug 
Administration district offices the same information for firms within 
the geographical area of such district office. Upon request, 
verification of registration number or location of a registered 
establishment will be provided.
    (b)(1) The following information filed under the device listing 
requirements will be available for public disclosure:
    (i) Each form FDA-2892 submitted;
    (ii) All labels submitted;
    (iii) All labeling submitted;
    (iv) All advertisements submitted;

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    (v) All data or information that has already become a matter of 
public knowledge.
    (2) Requests for device listing information identified in paragraph 
(b)(1) of this section should be directed to the Center for Devices and 
Radiological Health (HFZ-308), Food and Drug Administration, Department 
of Health and Human Services, 9200 Corporate Blvd., Rockville, MD 20850-
4015.
    (3) Requests for device listing information not identified in 
paragraph (b)(1) of this section shall be submitted and handled in 
accordance with part 20 of this chapter.

[69 FR 11313, Mar. 10, 2004]