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Exclusion of Evidence: The FDA's 510K Process
In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent U.S. Food and Drug Administration (FDA) approval, so the balance of its safety and efficacy has already been determined by the federal government to warrant distribution of the product. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken. Still, device makers have shown themselves anxious to present evidence of 510(k) approval to juries considering whether their products are safe for patients to use. Is the fact of 510(k) approval a relevant piece of evidence in this regard?
510(k) Approval
Manufacturers of medical devices that are intended for human use must obtain FDA approval before distributing them in the marketplace. They generally do so through compliance with the Medical Device Amendments of 1976 (MDA) to the Federal Food Drug and Cosmetics Act (FD&C Act), which became law on May 28, 1976, and which were enacted in order to “impose[ ] a regime of detailed federal oversight” over medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). In accordance with the MDA, medical devices are sorted into three categories — Class I, II, or III. Devices in Class I (such as dental floss) are the least dangerous and invasive types of devices, and receive the least federal scrutiny before they can be sold. Those in Class III are the most important for supporting life or preventing illness, and/or are those that pose the most risk. Therefore, Class III medical devices receive the most government scrutiny prior to approval — any such device entering the market after May 28, 1976, must go through the premarket approval (PMA) process.
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