The Food and Drug Administration is rolling out a handful of new guidelines aimed at fostering medical device innovation by allowing manufacturers to make small iterative modifications to their products and software.
The four guidance documents released on Tuesday, including finalized guidance (PDF) on when to submit a 510(k) for a software change in an existing device, represent the FDA's desire to keep pace with fast-evolving medical technology that often benefits from small modifications and upgrades, while ensuring those devices meet the same rigorous safety and efficacy standards.
But the guidance documents may only provide marginal relief given the stringent regulations that are still in place, according to Bradley Merrill Thompson, a medical device attorney with Epstein Becker & Green.
In addition to finalized guidance addressing software upgrades, the FDA also released finalized guidance (PDF) on making any type of change to a medical device, as well as draft guidance (PDF) on breakthrough devices, outlining a program under the 21st Century Cures Act that streamlines the FDA approval process for devices that can diagnose or treat life-threatening illnesses.
The FDA’s Center for Devices and Radiological Health also unveiled its first qualified Medical Device Development Tool, a program designed to assist with more robust and efficient medical device development, FDA officials wrote in a blog post. The approved tool, called the Kansas City Cardiomyopathy Questionnaire, focuses on measuring patient-reported outcomes for patients with congestive heart failure.
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For the mHealth industry, the finalized guidance on 510(k) submissions for software changes is perhaps the most notable, Thompson said in an email to FierceHealthcare. He added that developers are not as put off by the idea of getting FDA approval for a device as they are about resubmitting their device for every software update.
“Software development is highly iterative based on feedback, and the idea of seeking FDA clearance for every improvement makes many entrepreneurs sick to their stomachs,” he wrote.
The FDA, under Commissioner Scott Gottlieb, M.D., appears sympathetic to the intestinal ailments of developers. On Tuesday, Gottlieb advocated for slightly more leeway for manufacturers as long as changes to the software do not introduce new risks or harm or impact the clinical functionality of the device.
“Medical device technology evolves quickly,” Gottlieb said in a statement. “The process for improving the performance and clinical characteristics of medical devices is highly iterative. Often it’s the case that small modifications help provide incremental but meaningful improvements to products. Over time, these cumulative advances are consolidated into more noticeable advances in the performances of different technologies. Therefore, it’s important for the FDA to enable innovators to have the flexibility to efficiently make these kinds of small modifications.”
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But Thompson also points out that the FDA is operating under fairly rigid regulations that require a new 510(k) submission for any changes that significantly impact the safety and effectiveness of the device. The guidance documents, although helpful to industry, won't change those regulations.
For that reason, any new shift may be marginal at best, but it also places even more weight on the success of the FDA’s precertification pilot program that is currently underway. By solidifying a new paradigm for medical technology that focuses on the developer rather than the product, the FDA can streamline its process both for initial approval and for ongoing updates to medical devices.
“That’s where I know industry would like FDA to focus its time and attention,” Thompson said. “That’s where the greatest opportunities for improvement reside.”