OPMAD CDRH stands for Office of Product Manufacturing and Development within the Center for Devices and Radiological Health. This is a specific organizational division within the Food and Drug Administration (FDA) that focuses on regulating and overseeing the manufacturing and development of medical devices and radiological products.
The Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety, effectiveness, and quality of medical devices and radiological products used by healthcare professionals and patients. Within this center, the Office of Product Manufacturing and Development (OPMAD) plays a crucial role.
OPMAD CDRH is responsible for various regulatory activities related to the manufacturing and development of medical devices and radiological products. This includes reviewing and evaluating applications for product approval, inspecting manufacturing facilities for compliance with regulations and quality standards, conducting research on emerging technologies, and providing guidance and support to manufacturers throughout the product development process.
The primary objective of OPMAD CDRH is to protect public health by ensuring that medical devices and radiological products are safe, effective, and of high quality. By regulating the manufacturing and development processes, OPMAD CDRH aims to minimize the risks associated with these products and promote their safe use in healthcare settings.
In summary, OPMAD CDRH is an organizational division within the FDA's Center for Devices and Radiological Health that focuses on regulating and overseeing the manufacturing and development of medical devices and radiological products to ensure their safety, effectiveness, and quality.
