Dive Brief:
- The Food and Drug Administration extended the deadline Tuesday for commenting on the use of digital health technologies (DHTs) in the detection of prediabetes and Type 2 diabetes.
- Officials put out a request for feedback in November and gave people until Jan. 31 to respond. On Jan. 30, the FDA extended the deadline until Feb. 29. Four comments were published on the online docket as of Wednesday morning.
- The deadline is the only change. The agency is continuing to seek answers to questions about how DHTs, including those that use artificial intelligence or machine learning (AI/ML), could be used in the detection of prediabetes, Type 2 diabetes and undiagnosed Type 2 diabetes.
Dive Insight:
The FDA believes the healthcare sector is yet to realize the full potential of DHTs in the detection of diabetes, “especially in diverse populations, particularly racial and ethnic minorities.” The agency sees the technologies as an enabler of the focus on health equity that it laid out in its strategic plan for 2022 to 2025.
Seeking to further the plan, the FDA’s Center for Devices and Radiological Health is collecting responses to 14 questions about the use of DHTs in diabetes detection. The questions cover the work of community groups and consortia, scientific basis for the DHTs, outcomes that could be measured and how to integrate and implement the technologies into clinical workflows.
One comment was posted on the docket on Regulations.gov in December, and three more were posted on Tuesday, the day the agency extended the deadline. The comments submitted to date come from a consultant, an AI startup, a diagnostic company and physicians who wrote a paper on detecting Type 2 diabetes “using deep learning from frontal chest radiographs.”
While the comments cover some of the questions posed by the FDA, the agency lacks feedback on many of the points it wants to discuss in the consultation.