Both manufacturers and the public are putting the pressure on the FDA for fast, safe approvals. Until recently, manufacturers often sought quick approval for their devices by claiming they were equivalent to ones previously approved. The pathway for expedited approval, known as a 510(k) clearance process, began in 1976. In some cases, new products and devices were preapproved based on comparisons to old technology. Unsurprisingly, this led to claims that approved devices weren’t vetted thoroughly enough, and manufacturers bore the brunt of that.
This combination of shaky comparisons and limited clinical knowledge have created a system that’s no longer relevant in today’s healthcare market. A better one would include predicates based on current technology, greater levels of clinical trial activity, and plenty of RWE to verify product safety and effectiveness. As the FDA’s approval system moves toward the future, medical device manufacturers should follow in kind. Here are three important things for manufacturers to consider when working with new approval systems.