FDA-related regulations The US decrees related to the management of medical devices mainly include the following three:

*The Federal Food, Drug & Cosmetic Act of 1038 (FD&C Act of 1938). There were three major amendments to this Act after 1938, namely:

‧The Medical Device Amendments of 1976 (The 1976 Amendments)

‧The Safe Medical Devices Act of 1990 (SMDA)

‧Medical Devices Amendments of 1992 (The Medical Devices Amendments of 1992, referred to as the 1992 Amendments)

*Public Health Service Act

*Fair Packaging and Labeling Act

The 1938 FD&C Act prohibits the sale of shoddy and improperly packaged medical devices to the market. The 1976 Amendment significantly amended the relevant provisions, authorizing the FDA to strictly control all medical devices before they are marketed to ensure their efficacy and safety. Control measures include classification, premarket notification, premarket approval, investigational device exemption, good manufacturing practice, and postmarket surveillance. Surveillance), etc., and also strengthens the FDA's jurisdiction over post-marketing products, such as maintenance, replacement, reporting, recording, and marketing of specific products, especially the quality system requirements (GMP) for manufacturers, which makes the United States have medical devices. control is more complete.

The 1990 amendments focused on: medical device report, tracking management of permanently implanted, support or life-sustaining devices, device design changes, postmarket surveillance, fines, recalls, and In requesting FDA to revise the GMP provisions and increase the requirements for design control.

In 1992, the details of the 1990 SMDA were revised, adding the humanitarian device exemption (humanitarian device exemption), and special controls and PMA reviews could not be applied to special devices using less than 4,000 patients to encourage manufacturers to develop Special medical equipment for a small number of patients.

In addition, the Public Health Service Law mainly stipulates control measures for biological agents (such as serum, blood, vaccines, etc.) and radiation equipment. The packaging and labelling rules detail the packaging and labelling requirements for products.