What Does SCGD Stand For?

SCGD stands for Special Controls Guidance Documents

SCGD, or Special Controls Guidance Documents, are regulatory documents issued by the FDA that provide detailed information and recommendations for the development, manufacturing, and testing of medical devices deemed to require additional regulatory oversight. These documents help manufacturers ensure compliance with specific requirements and standards, supporting the safe and effective use of their products while facilitating the regulatory review process. SCGD serves as a vital resource for both industry stakeholders and regulatory bodies in navigating the complexities of medical device regulation.