The FDA’s regulatory pathways are the gold standard in providing safe and effective medical technologies for providers and patients. It is critically important that medical technology innovators have a predictable regulatory pathway to the market. The variability that existed over the years resulted in costly delays, and in some cases forced companies to shut down. An unpredictable and unreasonable regulatory environment leads to patients unable to access to safe and effective products.
Additionally, there has been no credible evidence to suggest that the current premarket review of medical devices is inadequate or unsafe.