WASHINGTON – The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), issued the following statement from Executive Director Patrick Hope on FDA’s 510(k) modernization plan:

“Medical imaging manufacturers are committed to protecting patients and innovating the latest breakthroughs to improve healthcare for all Americans. Because our top priority is—and always will be—patient safety, we look forward to working with the FDA as it seeks to modernize the 510(k) clearance process that has been widely recognized as the ‘gold standard for safety and effectiveness’ for more than four decades.

“It is important to recognize that the overwhelming majority (approximately 80 percent) of medical devices cleared through the 510(k) pathway are based on a predicate device less than a decade old. We are concerned that the proposed 10-year cutoff for predicate devices is arbitrary and will not necessarily lead to more effective, affordable, and accessible medical devices on the market. Predicate devices that are ten years or older offer a wide array of detailed performance data, which helps device makers further optimize their products.
“We encourage the FDA to appropriately balance safety and innovation as it considers reforms to the highly successful 510(k) program.”

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