21 CFR 822.23
§ 822.23 Is the information in my submission considered confidential?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 822.23, § 822.23 Is the information in my submission considered confidential?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88945
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92f45a0c94b413c7c2ebf84dce207789c86f26e733f41966f765ac8296ca48e1
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Full text
We consider the content of your submission confidential until we have approved your postmarket surveillance plan. After we have approved your plan, the contents of the original submission and any amendments, supplements, or reports may be disclosed in accordance with the Freedom of Information Act. We will continue to protect trade secret and confidential commercial information after your plan is approved. We will not disclose information identifying individual patients. You may wish to indicate in your submission which information you consider trade secret or confidential commercial.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.