The Food and Drug Administration plans to select about 40 devices not yet cleared by the agency to receive special agency discretion to participate in the new chronic care Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.
The FDA announced the model Thursday at a gathering of health tech stakeholders in Washington, D.C., to flesh out the new, 10-year CMS Innovation Center (CMMI) model.
The ACCESS Model would offer stable, recurrent payment for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety that meets certain clinical outcomes that have not yet been defined.
In most cases, devices used to treat chronic conditions would have to undergo review by the FDA and be cleared for that use, it wrote in a notice about the program. The new pilot, called TEMPO, will allow the agency to offer enforcement discretion to devices in the ACCESS program that have not yet undergone the FDA premarket authorization process.
TEMPO stands for Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot (“TEMPO pilot”). The pilot program expects to select about 10 devices for each condition category laid out by the CMMI in the ACCESS model.
The four categories are early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health, equaling 40 total devices across the condition categories.
The FDA said it wants to enroll a diverse array of manufacturers in the program and will select participants accordingly. The devices must be intended for use in the outpatient setting in conjunction with a clinician.
The devices may use off-the-shelf computing platforms or wearable devices, FDA wrote, including devices that leverage artificial intelligence.
Procedures for device manufacturers to participate in TEMPO include device description, data to demonstrate safety and patient benefit, a plan for mitigating risk to patients and providers, proposed performance goals and a proposed timeline for data collection and submission of a premarket notification to FDA.
The agency also expects the device manufacturers will use the opportunity to collect more evidence on the use of their device that will help with eventual FDA authorization.
“FDA recognizes that real-world data (RWD) may be collected in the course of clinical practice during the treatment and management of patients, particularly with the use of digital health devices,” the agency wrote in a notice. “Under certain circumstances, RWD may be used to generate real-world evidence (RWE) that can help inform or augment FDA’s understanding of the benefit-risk profile of devices at various points in their life cycle.”
Manufacturers can send in their requests for participation starting Jan. 2. The agency expects to respond to interested parties by March 2.
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