§ 807.37. Public availability of establishment registration and device listing information.
227 words·~1 min read·
/us/cfr/t21/s§ 807.37·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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 website, 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 Imports and Registration and Listing Team, Division of Regulatory Programs 2, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, 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, as amended at 85 FR 18442, Apr. 2, 2020]