mister

FDA Guidance Docs are topic-specific and should be read and evaluated for applicability. Generally, companies should consider Guidance docs to have same force as Sec 820 regulations. The FDA normally publishes Guidance to clarify issues in CFR, or to provide updated material. FDA archives Guidance docs on their website, but companies should keep important guidance items [...]

These are statutory laws published in the Code of Federal Regulations, CFR.  Primarily documented in Sec 820, they create the legal foundation for compliance. Company management should be familiar the scope and content of this material. They are also the foundation of ISO 13485.