Who compiles the GMP requirements for medical equipment?

The U.S. Food and Drug Administration (FDA) compiles the Good Manufacturing Practice (GMP) requirements for medical equipment. The FDA is a regulatory agency responsible for ensuring the safety, efficacy, and security of medical devices, among other categories of products.

GMP regulations established by the FDA are designed to ensure that medical devices are consistently produced and controlled according to quality standards. These requirements are essential for manufacturers to follow in order to ensure that their products are safe for public use. The FDA outlines specific guidelines and practices that should be adhered to during the manufacturing process, thereby protecting public health.

While other organizations, such as JCAHO, ECRI, and the International Standards Organization, focus on various aspects of healthcare quality, patient safety, and standards development, it is the FDA that is specifically tasked with the regulation and enforcement of GMP for medical equipment in the United States.