The FDA uses guidance documents as suggestions for how a company might comply with a particular regulations. Because guidance documents don’t go through the formal rulemaking process, they do not have the force of law.

The FDA releases guidance on many topics. Like laws and regulations, the guidance documents are available on the FDA’s website. Anyone dealing with a regulated product should consult the current, FDA guidance when developing company policies and standards, or any time when a person is dealing with a question regarding compliance with FDA.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.