The Safe Medical Device Amendments of 1990 was signed into law on November 28, 1990. The objective intent for Congress amending the Food, Drug, and Cosmetic Act was to provide greater assurance regarding the safety and effectiveness of the 1700 types of medical devices that FDA regulates. The new legislation gave FDA additional authority to obtain earlier knowledge of serious device problems, remove defective products from the market more quickly, and track devices from the manufacturer to the consumer.
The law codified the process that permits determination of substantial equivalence to devices already on the market before the 1976 Medical Device Amendments to be marketed without going through a full approval process. In the past, the agency had asked manufacturers for additional data, and now has explicit authority to require manufacturers to submit clinical data to establish that a device is as safe and effective as the device to which it is being compared.
The FDA required manufacturers of products that do not undergo the full-scale approval process to include in their premarket submission, a summary of safety and effectiveness information associated with their devices, or a statement agreeing to make the information available to the public upon request.
The SMDA expanded medical device reporting, already required of manufacturers, to hospitals, nursing homes, and outpatient treatment and diagnostic facilities to include reporting deaths and life-threatening illnesses and injuries attributed to devices.
Under this law, manufacturers of certain permanent life-sustaining or life-supporting devices are required to adopt an effective system of tracking those devices. They would have to maintain records to speed user notification when problems arise.
The 1990 amendments emphasize stronger enforcement authority and allow FDA to order a recall to remove defective products from the market, apply civil penalties for violations of the act, and temporarily suspend premarket approval of products that are found to be hazardous to health.
The law also allowed FDA to use special controls such as guidelines, standards, and postmarket surveillance studies to ensure the safety and effectiveness of devices that need additional controls in order to be safely marketed. Before a device was mass produced, FDA could require manufacturers to conduct design – validation activities to ensure that the device will operate as intended.
In addition, Congress added a humanitarian provision to allow devices to treat or diagnose conditions of diseases affecting fewer than 4000 people to be approved with less effectiveness data than is otherwise required.