Technology-Enabled Meaningful Patient Outcomes – TEMPO has been launched by the US Food and Drug Administration – FDA which is a pilot that looks to promote patient access to a set of digital health devices.
FDA’s Center for Devices and Radiological Health – CDRH has been developed by TEMPO and is being undertaken to assess a new, risk-based enforcement approach in order to support patient access to digital health devices.
Due to start in January 2026, the FDA is looking at around ten manufacturers in order to participate in the TEMPO pilot. Chosen devices of the participants must apply to the management of intricate cardiometabolic conditions, musculoskeletal issues, or even behavioral health conditions.
The scheme will enable the FDA to exercise enforcement discretion pertaining to regulatory dictates like premarket authorization and also investigational device requirements as the manufacturers collect as well as share real-world data demonstrating performance of the device.
Through working with participants in the Technology-Enabled Meaningful Patient Outcomes pilot so as to identify the circumstances when enforcement discretion may be apt, the FDA said the purpose of the pilot is to align with the rapid and iterative nature of the digital health development and also expand patient access to innovative technologies.
Michelle Tarver, CDRH director, said that the digital health technologies are fast transforming how people can go ahead and manage chronic conditions, and they also want to make sure that their regulatory approach keeps pace.
He added that the TEMPO pilot is indeed going to allow them to responsibly encourage the innovation while at the same time collecting real-world evidence, which may as well help them to better understand how such devices go ahead and perform for patients when it comes to their everyday lives.
The TEMPO pilot also goes on to sync with the Advancing Chronic Care with Effective, Scalable Solutions – ACCESS model of the US Centers for Medicare and Medicaid Services – CMS.
Apparently, the participating manufacturers in the pilot are going to offer their devices for care provisions that will be covered by ACCESS, which is an initiative that aims to grow the access of Medicare-Medicaid beneficiaries to technology-enabled and integrated care, while at the same time collecting, tracking, and also reporting the real-world performance data.
Marty Makary, the FDA commissioner, explained that they are piloting an approach in order to encourage the usage of digital technologies, which go on to meet people where they are.
He added that this pilot supports innovative tools and also a health care delivery model, which could very well enhance care for millions of Americans so as to manage chronic disease.