Medtronic Lawyer, Williams Kherkher

The Medical Device Amendments of 1976

The Medical Device Amendments were passed in 1976 to add to the Food, Drug, and Cosmetics Act of 1938. The FDCA created the Food and Drug Administration (FDA). The MDA of 1976 granted the FDA oversight and approval of medical devices, something that had been left out in the FDCA of 1938.

The Medical Device Amendments created a scheme of federal safety oversight for medical devices. At the same time, it pushed back state oversight laws. States were now prohibited from establishing or continuing any scheme of regulation which was different from or in addition to any requirement applicable under federal law. In addition, the states were prohibited from creating rules that relate to the safety or effectiveness of a medical device or to any other matter included in a requirement applicable to the device under relevant federal law.

The level of federal oversight of medical devices varies with the type of device that is at issue. There are three broad classes of devices, Class I, II, and III. Medical devices are classified based on their risk to consumers. Class I devices, which include such things as tongue depressors, are subject to minimal control and oversight because of their generally accepted safety standards. Class II devices, including such devices as tampons, are subject to more specialized controls that may include performance standards or specific guidelines. Class III devices are subject to the most strict levels of control and oversight. These devices must undergo a stringent Pre-Market Approval (PMA) process due to the role they play in saving lives. Class III includes such items as pacemakers and internal Cardioverter defibrillators.

The MDA of 1976 also include two exemptions for Class III devices and the PMA process. If a medical device was on the market by 1976, it is exempt from the PMA process. The other exemption involves devices that are substantially equivalent to devices that are already approved by the FDA. If an item’s predecessor was approved, the new version of it does not have to be approved.

If you have been given a Medtronic defibrillator featuring Sprint Fidelis leads, contact the Medtronic lawsuit lawyers of Williams Kherkher at 800-761-3187 to discuss your case and to determine your legal options.