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“Imagine the benefits of a more efficient and transparent pathway,” the FDA Commissioner wrote in a new blog post.
Less than a week after announcing 3 new guidance documents to streamline the review of digital health, the FDA is moving to refine its 510(k) medical device approval pathway.
Set forth in the Medical Device Amendments of 1976, the 510(k) pathway primarily concerns moderate-rick medical devices. Because it was implemented more than 40 years ago, FDA Commissioner Scott Gottlieb, MD, today wrote that, “there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies, and how we must evaluate those technologies.”
New devices must demonstrate comparable efficacy to older ones. Technologies like ultrasound imaging and blood pressure monitoring are well-understood, but new devices can approach those applications in novel ways. Asking manufacturers to compare their devices to decades-old technologies can be a “burden,” Gottlieb wrote. “Imagine the benefits of a more efficient and transparent pathway.”
As a result, the agency will be publishing a new draft guidance in the first quarter of 2018 to outline a voluntary alternative model for demonstrating equivalence. “This pathway would be available for pre-specified categories of mature devices — those for which safety and performance criteria that meet or exceed the performance of existing, legally-marketed devices can be identified,” Gottlieb wrote.
The guidance will also detail how the FDA plans to make assessments of pre- and post-market adjustments and data when evaluating devices. The goal, Gottlieb writes, is to put forth a more objective and transparent understanding of acceptable risk uncertainty and public health need for a given technology. The level of public health need, based on severity of illness and size of applicable population, will be important considerations.
“FDA might accept greater uncertainty for a device where gathering extensive clinical evidence pre-market would not be feasible given the small patient population that the device is intended to treat,” he wrote. If uncertainty can be resolved through post-market data, like from registries, it may change what is required of pre-market applications, although the agency “must have confidence” it will be able to acquire that data.
The new pathway will be available to pre-specified categories of mature devices. Innovation is at the core of the plan, according to Gottlieb: “We must provide more opportunity to enhance traditional products with new advances, and to use these same innovations to develop fundamentally novel devices altogether,” he wrote.