[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: 21CFR807.37]

[Page 66]
 
                        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 FD-2891 and FD-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-342), 
Food and Drug Administration, Department of Health and Human Services, 
1390 Piccard Dr., Rockville, MD 20850. 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 FD-2892 submitted;
    (ii) All labels submitted;
    (iii) All labeling submitted;
    (iv) All advertisements submitted;
    (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-342), Food and Drug Administration, Department 
of Health and Human Services, 1390 Piccard Dr., Rockville, MD 20850.
    (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.

[43 FR 37999, Aug. 25, 1978, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990]