New FDA guidances aim to increase clarity on when developers need to resubmit 510(k)s

By Jonah Comstock
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The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program.

"Medical device technology evolves quickly. The process for improving the performance and clinical characteristics of medical devices is highly iterative," FDA Commissioner Dr. Scott Gottlieb wrote in an announcement. "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. At the same time, the FDA needs to establish modern tools and benchmarks for measuring the safety and performance of devices to make sure they’re delivering the expected benefits to patients."

The two final guidances released today are designed to help developers understand when a modification to a device — which would include a software update — requires a new 510(k) clearance. The guidances, "Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” update a similarly-named guidance document from 1997.

"These new guidance documents do not change the FDA’s review standard: A new 510(k) is required when a marketed device has changes, including changes to software, that could significantly affect the safety or effectiveness of the device or when there are major changes in the intended use of the device," Gottlieb explained. "Instead, the new policies enhance predictability and consistency for innovators deciding when to submit new 510(k)s by better describing the regulatory framework, policies, and practices underlying such a decision."

Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA regulation of mobile and digital health, told MobiHealthNews that the move is welcome, but likely doesn't go far enough.

"When I talk to people in the mHealth industry, while none of them are thrilled with the idea of getting FDA clearance for their mobile apps, what they really fear is the obligation from that point forward to keep the FDA clearance up-to-date with changes in the software," he said in an email. "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. FDA seems to be getting that message."

The problem, Thompson says, is that there's only so much the FDA can do within its own rules, which dictate a lot of circumstances in which a device needs new clearance. This new guidance only draws attention to the need for something like the FDA Pre-Certification Program, which, if it successfully moves past the pilot phase, would alleviate the need for these sorts of updates completely.

"The new guidances announced today for device modifications may be helpful, but we won’t know that really until we’ve studied the very specific language and see how it allows for important software updating to occur with minimal FDA oversight," Thompson said. "But if it’s an improvement, it’s only a marginal one. Until we change the regulation and shift the agency’s focus to the software vendor, rather than engaging in individual product review, any gains will be small at best."

In addition to the two new final guidances, the new draft guidance describes the FDA's new Breakthrough Devices Program, which will supercede the agency's Expedited Access Pathway. The program, which allows novel technologies that present a significant improvement over the status quo to move more quickly through the clearance process, was created in the 21st Century Cures Act that passed last year.

Finally, the FDA announced that it has qualified the first tool under its MDDT program, in which the agency creates a list of qualified tools that can be used to evaluate interventions going forward. The first qualified tool is the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ), a Clinical Outcome Assessment that measures patient-reported outcomes from patients with congestive heart failure.

"FDA relies on sound science in its decision-making, which provides medical device innovators with a strong base for their product development," US Public Health Service Captain Hilda Sharen and Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, wrote in a blog post. "Part of good science is relying on tools to efficiently and accurately measure the product’s performance at all points in the process. Finding those accurate, efficient, and reliable tools can be challenging, especially given the diversity of technology and of medical devices. That’s where FDA’s voluntary [MDDT] program can help."