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FDA Announces Plans to Modernize 510(k) Device Approval Process

This week, the FDA announced it was considering modifications to the 510(k) device approval process to ensure approval decisions made through this pathway are based on modern technology. Under the 510(k) process, device manufacturers can bypass the more rigorous device approval process for devices that are substantially similar to previously approved devices, known as predicates. The FDA notes that there are no restrictions on what devices may serve as predicates for new 510(k) devices and, consequently, many new devices are predicated on others that may be decades old and do not use the same technologies available today. To modernize the process, FDA is considering a plan to post information about predicates on its website and potentially note when the predicate device is more than 10 years old. FDA noted that, overall, it is seeking to expand the use of the 510(k) process as a means of ensuring new device technologies are available sooner and believes the proposed modifications will continue to ensure the safety and effectiveness of those devices. We will keep you updated.