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New FDA Guidance Docs Aim to Nurture Medical Device Innovation


The agency continues to refine its device clearance process in accordance with the 21st Century Cures Act.

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Scott Gottlieb, MD, has often said the US FDA is attempting to evolve its approach to new therapies and devices. Today, the agency released 3 news sets of guidance documents for medical device update and approval, and the commissioner issued a corresponding statement.

The first of the 3 documents is a draft guidance on the “Breakthrough Devices Program” created by the 21st Century Cures Act. The new voluntary program, which supersedes both the existing Expedited Access Pathway and the Priority Review Program, intends to “enable a more agile pre-submission process.” The draft guidance is currently open for comment.

The other 2 items released today cover submission of 510(k) premarket notifications for updates to existing software or devices.

Noting how quickly medical device technology is progressing, Gottlieb said it’s critical for manufacturers to make necessary, incremental updates without subjecting their devices and software to a comprehensive review process each time. “This improved clarity will help lower the barriers to innovation and improve patient care by reducing unnecessary submissions to the FDA for changes that could not significantly affect device safety or effectiveness,” he wrote.

Still, he added that “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.”

To that end, the agency plans to release medical device development tools, the first being a voluntary 23-item questionnaire. Device makers can dispatch the questionnaire, in this case pertaining to heart failure, directly to patients with the condition in order to inform development of their devices on a series of metrics already established and validated by the regulatory agency. Gottlieb wrote that he expects the FDA to create additional tools in coming months.

“Such development tools can also help minimize the use of animal studies, reduce the duration of testing, or require fewer patients in a study by optimizing patient selection or improving on the ability to measure benefit and risk through the availability of measurements that are more sensitive for assessing these outcomes,” he wrote.

Gottlieb pointed to the wearable devices sector as a valuable field there the FDA’s regulatory tools might be applicable.

The FDA has been working this year to pave smoother paths for innovators. In September, for example, it announced the names of 9 companies that would participate in a pre-certification pilot program for digital health software.

Giants like Apple, Johnson & Johnson, and Fitbit signed on to the program, hoping to work with regulators to develop best practices for bringing tech upgrades to market sooner. Much like medical devices, healthcare software tends to demand quick fixes, and the tech almost never stops moving forward, FDA officials and industry leaders said.

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