This facet of FDA authority is represented primarily through
the development and publishing of Guidance Documents.
Guidance documents are generally provided as “advice”,
or methods by which the regulations can be met. Although they
are technically “guidance” and not law, they are used
by the courts to interpret the law. FDA’s position on the
use of guidance is that a researcher is free to use other means
to fulfill the requirements of the law if they have an equal or
better process than that which is detailed in the Guidance documents.
This is the “rule-making”. Title 21 of the CFR is
considered “rules” or regulation. Regulation has all
the force of law.
The FDA is empowered with judicial, legislative, and executive
authority. This means that the FDA writes regulations with the
force of law, judges whether the law has been followed, and assigns
penalties based on their assessment of the severity of the infraction.
Violation of FDA regulation can be considered a criminal offense.