The FDA is rolling out a pilot program to ease digital health regulations and push tech innovation in the fight against chronic disease.
The agency plans to select up to 10 device manufacturers in each of four clinical areas for its new TEMPO project, aka Technology-Enabled Meaningful Patient Outcomes. Companies can submit statements of interest beginning in January.
“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” FDA Commissioner Marty Makary, MD, stated in a Dec. 5 news release. “This pilot supports innovative tools and a healthcare delivery model that could improve care for millions of Americans managing chronic disease.”
Participating manufacturers can request enforcement discretion for such requirements as premarket authorization and investigational device rules, as long as they target chronic conditions like back strain, depression, heart failure and prediabetes.
The FDA said the program ties in with CMS’ new ACCESS pilot project to reimburse healthcare organizations for better managing chronic diseases with technology. HHS Secretary Robert F. Kennedy Jr. has pledged a widespread increase in Americans’ use of wearables.
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