In the past six months, there has been a flurry of announcements from federal agencies emphasizing speed and efficiency in getting medical devices and therapeutics to patients. The US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched three pilot programs that medtech companies should be aware of:
- The Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
- The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway
- The FDA's announcement of two proof-of-concept real-time clinical trials (RTCT) and a broader pilot beginning this summer
Each program is different in scope, but together they represent a more coordinated federal approach to reducing the time between development and patient access. Medtech companies planning their regulatory and clinical strategies should understand the details and the impact of each.
Here's what each program does and who it affects.
TEMPO: FDA's enforcement discretion pilot for digital health devices
Announced in December 2025, the TEMPO pilot is a voluntary enforcement discretion program. Participating manufacturers may request that FDA set aside certain premarket authorization and investigational device exemption requirements while they collect and share real-world performance data from their products.
To be clear, TEMPO is not a new regulatory pathway. FDA expects the data generated, along with any additional supporting information, to ultimately support a 510(k) or other marketing submission. In other words, TEMPO defers authorization requirements, but it does not eliminate them.
The program targets digital health devices intended for four specific clinical use areas within the CMMI ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) model:
- Early cardio-kidney-metabolic conditions (hypertension, dyslipidemia, obesity, prediabetes)
- More complex cardio-kidney-metabolic conditions (diabetes, chronic kidney disease, atherosclerotic cardiovascular disease)
- Chronic musculoskeletal pain
- Behavioral health conditions (depression or anxiety)
Devices must not already be FDA-authorized for an intended use to improve patient outcomes in one of these areas. A cleared device could still be eligible if its existing authorization does not cover that specific intended use.
Enforcement discretion under TEMPO applies only when the device is offered through the CMMI ACCESS model. It does not extend to general commercialization. A manufacturer whose device is accepted into the pilot cannot market that device for the same intended use outside of the ACCESS model without separate FDA authorization.
FDA is selecting up to approximately 10 manufacturers per clinical use area. Statements of interest opened Jan. 2, 2026, and FDA began sending follow-up requests to potential participants around March 2, which means the initial selection phase is likely underway. When FDA follows up, it requests a device description, safety data, a real-world performance data collection plan, proposed patient outcome goals, and information about the manufacturer's quality management system (QMS).
That last point matters: QMS maturity is an explicit evaluation factor in how FDA assesses TEMPO applicants. If there is a continuation or expansion of the TEMPO program, applicants will need to demonstrate a strong quality foundation. If you're not sure you'd be able to, it might be time to evaluate your QMS. Greenlight Guru's QMS software is built specifically for medtech companies that need a compliant, scalable solution. To learn more, get a demo today.
RAPID coverage: closing the gap between FDA clearance and Medicare coverage
Also announced in April 2026, the RAPID coverage pathway addresses a problem device companies have managed for decades. FDA market authorization does not automatically qualify a device for Medicare coverage. The two processes are separate, and historically the gap between them has run a year or more.
Under RAPID, CMS and FDA will coordinate earlier in the development process, before market authorization, so that clinical evidence generated for FDA review can simultaneously support Medicare coverage decisions. The pathway is limited to FDA-designated Class II and Class III Breakthrough Devices enrolled in an Investigational Device Exemption (IDE) study with Medicare beneficiaries, studying clinical health outcomes agreed upon by both agencies in advance.
Under RAPID, when an eligible device receives FDA market authorization, CMS will issue a proposed National Coverage Determination (NCD) the same day, triggering the 30-day public comment period. According to CMS, the result could be national Medicare coverage as soon as two months after market authorization, compared to approximately a year or more under the current process.
Keep in mind, RAPID applies to Breakthrough Devices, not all cleared or approved devices. It also requires IDE study enrollment of Medicare beneficiaries with pre-agreed clinical endpoints, which means evidence alignment has to be planned well before submission. CMS is also pausing the Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates as it focuses on implementing RAPID.
For teams pursuing FDA Breakthrough Device designation and planning IDE studies, the implication is direct: the design of your clinical evidence package now has downstream consequences for how quickly you can access the Medicare market. If your device qualifies for Breakthrough designation, the time to think about RAPID is during study design, not after clearance.
Real-time clinical trials: what medtech teams should know
On April 28, 2026, FDA announced two proof-of-concept real-time clinical trials (RTCT) and a request for information on a broader pilot program launching this summer. The trials announced are with AstraZeneca (a Phase 2 lymphoma study) and Amgen (a Phase 1b lung cancer study), which are both pharmaceutical studies, not device studies.
The real-time trials initiative as currently structured is a drug development program. The core mechanism is continuous real-time data sharing between trial sites, sponsors, and FDA reviewers, and it addresses a bottleneck in pharmaceutical clinical development that differs from the typical evidence generation pathway for medical devices.
The underlying principle, though, has clear relevance to medical device clinical trials. Device IDE studies face a version of the same problem. Data from studies flows sequentially rather than continuously, FDA review happens after submission rather than alongside data collection, and protocol amendments require formal submissions that slow adaptive adjustments. If the real-time trials model proves out in pharma, it's reasonable to expect FDA will look for ways to apply similar principles to device development, particularly for software-based and AI/ML devices where iterative evidence generation is already part of how these products work.
FDA is accepting comments on the real-time trials pilot RFI through May 29, 2026, and plans to complete pilot selections in August. Device companies with interest in adaptive trial designs or continuous data architectures should watch how the pilot develops, and consider whether submitting comments on the RFI is appropriate given their pipeline.
What all three programs have in common
TEMPO, RAPID, and the real-time clinical trials initiative each address a different point of friction in the path from development to patient access. TEMPO targets the premarket authorization burden for digital health in chronic disease. RAPID targets the year-plus delay between clearance and Medicare coverage for Breakthrough Devices. Real-time trials target the sequential, batch-submission structure of clinical evidence generation.
None of these programs reduces FDA's expectations for evidence quality or patient safety. What they signal is that FDA and CMS are willing to restructure their own processes to reduce administrative and timeline friction, provided companies can demonstrate performance through real-world data or pre-aligned clinical evidence.
The practical implication for medtech teams is that evidence strategy, clinical data infrastructure, and quality documentation are no longer just compliance requirements. They are the variables that determine whether you can participate in faster pathways, or whether your competitors who planned for them get there first.
How to build the quality and evidence infrastructure these pathways require
There is a lot in motion right now when it comes to how FDA and CMS are structuring access to patients. TEMPO, RAPID, and the real-time trials initiative will each continue to develop, and the details will keep changing.
What will not change is the underlying requirement that participation in any of these programs depends on the quality of your documentation, your data, and your evidence. Whether FDA is evaluating your QMS maturity as part of a TEMPO statement of interest, or CMS is relying on your IDE study endpoints to trigger a coverage determination, the companies that get access to faster pathways are the ones who built their quality and clinical infrastructure to support it from the start.
Greenlight Guru is purpose-built for medical device teams managing quality, design, and clinical evidence in a single connected system. If you want to see what that looks like in practice, get a free demo today.
BONUS RESOURCE: Change Impact Analysis Checklist
