21 CFR 807.37 - Public availability of establishment registration and device listing information.

§ 807.37 Public availability of establishment registration and device listing information.

(a) Establishment registration and device listing information is available for public inspection in accordance with section 510(f) of the Federal Food, Drug, and Cosmetic Act and will be posted on the FDA Web site, with the exception of the information identified in paragraph (b) of this section. Requests for information by persons who do not have access to the Internet should be directed to the Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 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 offices. Upon request, verification of a registration number or location of a registered establishment will be provided.

(b) The following listing information will not be available for public inspection or posted on the FDA Web site:

(1) For contract manufacturers, contract sterilizers, and private label manufacturers, the proprietary or brand name(s) under which a device is marketed and the FDA-assigned premarket submission number, if this information would reveal a confidential business relationship;

(2) FDA-assigned listing numbers.

[ 77 FR 45943, Aug. 2, 2012]

Title 21 published on 10-May-2017 03:43

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

  • 2016-10-17; vol. 81 # 200 - Monday, October 17, 2016
    1. 81 FR 71415 - Electronic Submission of Labeling for Certain Home-Use 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 January 17, 2017. In accordance with 21 CFR 10.40(c), in finalizing this rulemaking FDA will review and consider all comments submitted before the time for comment on this proposed regulation has expired. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 16, 2016; see section VI, the “Information Collection Requirements” section of this document. See section VIII of this document for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Part 807
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