CFR - Code of Federal Regulations Title 21

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2012]

[CITE: 21CFR807.37]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 807 -- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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 Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002. 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 Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002.

(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, as amended at 75 FR 20914, Apr. 22, 2010]