Glossary Term
Guidance Documents (FDA, ISO, EU)
Definition
Guidance documents are non-binding, advisory publications issued by regulatory bodies like the FDA, standards organizations such as ISO, or governing frameworks like the EU MDR. They provide recommendations, technical specifications, and best practices for compliance, development, testing, and marketing of medical devices. While not legally enforceable, these documents serve as valuable tools to ensure adherence to applicable regulations and standards.
Relevance to the MedTech Industry
Guidance documents streamline the development, manufacturing, and regulatory submission processes by clarifying expectations and providing frameworks for compliance. They ensure consistent application of regulations and standards, reducing ambiguity and improving efficiency for MedTech companies navigating complex regulatory landscapes.