(predictive tests that have gone through the FDA approval process). He began his talk by pointing out that “in personalized medicine, the companion diagnostic really becomes key, because if you’re going to be given a therapeutic, or you’re going to be taking a clinical action based on the companion diagnostic, the diagnostic has to be right.” The Medical Device Amendments of 1976 gave the FDA authority to regulate devices, including companion diagnostic tests, based on the amount of risk that is linked to the use of that device. Devices are classified into one of three risk categories (Classes I, II, and III), where Class I devices have the lowest level of risk and Class III devices have the highest.

The regulatory requirements necessary for approval of a device are based on the devices classification. Manufacturers of Class I devices, such as Band-Aids or pH tests, have to register their test with the FDA and follow general controls, such as adhering to good manufacturing practices, reporting device failures, and developing and using a system for remedying such failures (FDA, 2009b). The requirements for Class II devices are more complex. This is where most companion diagnostic tests fit into the classification scheme. Manufacturers of Class II devices need to follow FDA guidance documents that detail what manufacturers need to provide in order to receive FDA market clearance of their medical device, quality system regulations, and other special controls. They also must show that their device is substantially equivalent to a device that is on the market, or was on the market before 1976. This process is what the FDA calls “premarket notification (510(k))” (FDA, 2009b). Class III devices are the most complex and pose the highest degree of risk. Manufacturers of Class III devices are required to submit an application for Premarket Approval (PMA) to the FDA that details the safety and effectiveness of their device. The device cannot enter the market until after the FDA reviews and approves this application (FDA, 2009b).

In general, “the nice thing about this regulatory process is that it is quite malleable,” Dr. Gutierrez explained. “We can apply the necessary regulation depending on both the risk of your test and its complexity, so it allows the reviewers the ability to mold their regulatory process to what you have.” The FDA determines a device’s risk classification based on the intended use of the device. If a device has more than one intended use, it will have a separate review process for each use. For example, “you could have a device that is used for monitoring cancer, which will have a lower risk than a device that does screening for cancer, because if you tell somebody they don’t have cancer when, in fact, they do, you can actually put them at very high risk,” Dr. Gutierrez said.



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