FDA Annual Registration

Part 807 - - Establishment Registration and Device Listing for Manufacturers and Initial Imports of Devices

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;

(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]

Sec. 807.39 Misbranding by reference to establishment registration or to registration number.

Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

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