FDA reveals real-world pilot for digital health tools

 The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to market more quickly and easily.

In line with its deregulatory stance under new Commissioner Marty Makary, the US regulator has launched TEMPO – Technology-Enabled Meaningful Patient Outcomes – that will take the form of a voluntary pilot scheme "designed to promote access to certain digital health devices while safeguarding patient safety."

The TEMPO pilot will run within the Centers for Medicare and Medicaid Services (CMS) recently launched ACCESS model, which is testing an outcome-aligned payment approach for Medicare aimed at improving access to approved healthtech that is used for people with conditions like high blood pressure, diabetes and prediabetes, chronic musculoskeletal pain, and depression.

The FDA plans to select up to 10 device manufacturers in each of four clinical areas – which have not already gone through the usual premarket authorisation process – in the initial phase of the TEMPO project, and sponsors will be able to submit statements of interest starting in January 2026.

The four areas are early cardio-kidney-metabolic – which includes hypertension, dyslipidaemia, obesity/overweight, and prediabetes – along with later-stage cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease), chronic musculoskeletal pain, and behavioural health interventions of depression or anxiety.

"We are piloting an approach to encourage the use of digital technologies that meet people where they are," said Makary in a statement. "This pilot supports innovative tools and a healthcare delivery model that could improve care for millions of Americans managing chronic disease."

According to the regulator, participating manufacturers can request enforcement discretion for certain requirements, such as premarket authorisation and investigational device rules, as long as they target chronic conditions.

The FDA and CMS will work together on the TEMPO pilot, in which participating manufacturers will offer their DHTs for use while "collecting, monitoring, and reporting real-world performance data." The FDA will work with participants to identify the circumstances when enforcement discretion may be appropriate for a particular DHT.

The pilot will "allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives," commented Michelle Tarver, director of the FDA's Center for Devices and Radiological Health (CDRH).

Makary has said he aims to challenge with way medical products are regulated in the US while in office, taking the brakes off a system that he claims is holding the country back in an increasingly competitive international landscape. Other initiatives include the Commissioner's National Priority Voucher programme, which could see some medicines approved in weeks, rather than months, and a recently discussed move towards requiring only one pivotal clinical trial – rather than a pair – as the standard for showing safety and efficacy.

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