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CFR › Section 807.37

21 CFR 807.37 - Inspection of establishment registration and device listings.

There is 1 rule appearing in the Federal Register for 21 CFR 807. Select the tab below to view, or View eCFR (GPOAccess)
§ 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]

Title 21 published on 2012-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2012-08-02; vol. 77 # 149 - Thursday, August 2, 2012
    1. 77 FR 45927 - Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective October 1, 2012.
      21 CFR Part 807

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
USC : Title 21 - FOOD AND DRUGS

§ 360c - Classification of devices intended for human use

§ 360e - Premarket approval

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 393 - Food and Drug Administration

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 271 - Penalties for violation of quarantine laws

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 807 after this date.

  • 2013-02-25; vol. 78 # 37 - Monday, February 25, 2013
    1. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by May 28, 2013. See section VIII of this document for the proposed effective date of a final rule based on this proposed rule. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 27, 2013, (see the “Paperwork Reduction Act of 1995” section of this document).
      21 CFR Parts 807, 812, and 814