The United States began supervising medical devices early; medical devices were mentioned in the Food and Drug Act of 1906, and the management of medical devices was added to the Federal Food, Drug, and Cosmetic Act of 1938. In 1976, the Medical Device Amendment was released, and it confirmed the classification system of medical devices, enhanced supervision, and proposed custom-made medical devices for the first time. In 1990, the US Congress passed the Safe Medical Devices Act, which authorized the FDA to conduct postmarket safety supervision of companies that produce permanently implanted devices and gave the FDA the power to require the recall of noncompliant devices. In July 2012, the FDA Safety and Innovation Act officially went into effect, adding restrictions on the clinical use and postmarket management of custom-made medical devices. In September 2014, the FDA officially released guidance on “Custom Device Exemption,” which clarified the regulatory model for custom-made medical devices. From 2012 to 2021, the FDA strengthened its work on international standards related to medical devices, including the announcement of international standards recognized by the FDA and the development of compliance guidelines. In December 2017, the FDA officially released the Guidance Document Technical Considerations for Additive Manufactured Medical Devices to regulate the manufacturing of 3D-printed medical devices.