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US FDA expects to soon release its "digital health tools" platform that will allow software applications to be approved in conjunction with new drugs and included in labeling.

Under the plan, the software applications may not require separate approval by the Center for Devices and Radiological Health. Commissioner Scott Gottlieb said Oct. 24 that the digital health tools platform is expected to be unveiled in a couple weeks. The commissioner has previously signaled the agency's plan to advance a new policy framework on how digital health can be used in drug development and patient monitoring. (Also see "Gottlieb Unveils Next Steps In Digital Health Plan" - Medtech Insight, 26 Apr, 2018.)

"What we're looking to do there is incorporate the digital tools into the product labeling in a way that they can be regulated in post-market as part of the promotional labeling as opposed to just having to be regulated as a pre-market medical device and undergo pre-market review," Gottlieb said during an appearance at the Milken Institute Future of Health Summit. "This is going to help facilitate the development of more of these types of tools."

Gottlieb said the applications, which include software for a smart phone or smart watch, could help with compliance, such as ensuring a patient takes their medication. Tools also could use cell phone cameras to monitor adverse events or track cognitive performance.

They also potentially could measure outcomes for drug post-market surveillance or post-market commitments, and Gottlieb indicated the data could support "future regulatory decision-making," such as supplemental indications. (Also see "Leveraging mHealth Data For Product Development: FDA-Supported Action Plan Released" - Medtech Insight, 19 Sep, 2017.)



Gottlieb said tests such as the six-minute walk, while long accepted, are not the best way to measure physical performance. Now that smart watches and other devices can measure physical functions, he said, there may be opportunities to utilize them when new drugs are approved.

"I think that there are ways to incorporate technology that would allow us to gather that information in a much more objective fashion, more reliably, perhaps more quickly," Gottlieb said. "If you have better tools that are more sensitive to measuring change in physical symptoms and physical performance, you could potentially get an answer more quickly."

Gottlieb mentioned the digital health tools platform in the context of FDA's increasing focus on patients, including patient needs and opinions.

The agency and industry for years have been working on incorporating patient information into drug development, as well as the review process.

More Help For Combination Products?

The plan would seem to further streamline the approval process for some combination products.

Often problems arise when the drug and device portions of the product are not approved on the same timelines. FDA wants to allow more application reviews to be led by the Center for Devices and Radiological Health, which also could result in faster approvals. (Also see "Combo-Product Sponsors Could More Easily Get Device Designation At US FDA" - Pink Sheet, 29 Jul, 2018.)

In addition, the Office of Combination Products is preparing to implement a new meeting type that will allow non-binding sponsor-agency agreements on pre- and post-market issues. (Also see "US FDA Preparing For New 'Combination Product Agreement Meetings'" - Pink Sheet, 22 Oct, 2018.)

What role, if any, is envisioned for CDRH, which typically handles medical software, in the digital health tools platform was not clear from Gottlieb's remarks.

CDRH recently granted ade novoclassification to apps onthe latest version ofApple Watchthat monitor for abnormal heart rhythms. (Also see "US FDA Commish Defends Approach To Apple Approvals" - Medtech Insight, 28 Sep, 2018.)

A version of this article first appeared in the Pink Sheet.

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