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Manufacturers that fundamentally change designs of medical devices, after having received an approved application for premarket approval (PMA), or 510(k) clearance, must obtain an approved application. If they do not, the modified devices are adulterated and misbranded.
A common fact pattern is where the device has undergone design changes, in furtherance of an extension to the product line, since the device was initially cleared. Typically, the promotional material on a manufacturer’s website and product brochures tout the major changes or modifications to the intended use(s) of the device. These changes can include but are not limited to: design changes in how the product functions, design changes in how the product achieves its results, material changes, material size changes, and additional intended uses, to name a few.
Depending on how the expanded product line is reimbursed, damages can be substantial. Certain new technologies, which obtained approval through the PMA process, receive separate reimbursement. The new technology generally must represent a substantial clinical improvement relative to existing technologies and meet specific cost thresholds.
Medical devices cleared through the 510(k) process, however, are typically not new technologies, as they, at most, represent incremental improvements to medical devices and other technologies already on the market. Therefore, these devices are not separately reimbursed but rather bundled into the DRG or other composite payment.
Manufacturers of medical devices that have undergone fundamental changes without FDA approval or clearance run not only the risk of violating the federal Food Drug and Cosmetic Act, but also the federal False Claims Act.