Legal consequence
Legal consequence means the result of an action that directly or indirectly affects substantive legal rights or obligations, including by subjecting a regulated party to potential liability in an enforcement action. This includes agency letters or orders establishing greater liability for regulated parties in a subsequent enforcement action, but excludes communications that have no immediate regulatory implications for a person or entity, such as letters (e.g., warning letters) or inspectional observations that serve as an interim step in the agency's compliance communications with a person or entity or that are intended to encourage voluntary compliance.
Source
45 CFR § 1.2
Scoping language
The following definitions apply to all components of the Department until the Secretary amends the Food and Drug Administration's good guidance regulations at 21 CFR 10.115 to bring them into conformance with the requirements of 1.3 through 1.5 of this part: