Amidst the growing safety issues associated with moderate-risk medical devices, such as Depuy’s metal-on-metal hip implants, patient advocacy groups are stressing the need for a more rigorous pre-and-post market approval process. At present, medical devices can reach the market through two main regulatory processes. The first and most rigorous is the premarket approval (PMA) process. PMA requires the presentation of scientific evidence collected through clinical trials of safety and effectiveness for a device’s intended use. However, a quicker and cheaper way to gain FDA approval is for device makers to pursue the 510(k) pathway process. Using the 510(k) pathway, devices makers must only prove that an investigational device is substantially equivalent to, or just as safe and effective as, another device (a predicate device) that has already been cleared by the FDA.

Earlier this summer, the FDA commissioned a study to be conducted by the Institute for Medicine (IOM) in order to formally review the agency’s device approval process. Following completion of the study, IOM suggested that the FDA scrap the 510(k) pathway process altogether in order to allow for higher scrutiny of moderate risk devices. The FDA, somewhat shocked by the IOM’s recommendation, indicated that scrapping the 510(k) system wouldn’t be necessary. However, the agency did say it would remain open to fine-tuning the process. Regardless, it is clear that the FDA will need to balance safety concerns with the benefits of its 510(k) process.

In response to these concerns, the FDA has now issued draft guidance on the design of pivotal clinical studies to support pre-market approval applications for Class III devices, which are the highest-risk category of all medical devices (those that support or sustain life). This draft guidance released by the FDA is subject to a 90-day comment period.


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