Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use, a function that formerly had been in the Public Health Service.
Resources on the History of Device Regulation
- Medical Device & Radiological Health Regulations Come of Age
- Center for Devices and Radiological Health Directors and Deputies
- Center for Devices and Radiological Health Milestones
- A History of Medical Device Regulation & Oversight in the United States