Not So Fast: When “RAPID” Isn’t Enough

Parallel review. Medicare Coverage of Innovative Technology (MCIT). Transitional Coverage for Emerging Technologies (TCET). Each of these initiatives promised to close the persistent gap between FDA marketing authorization and CMS coverage for medical devices. None has fully delivered. Some were formally withdrawn; others simply faded from relevance.

Now comes the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway, announced on April 23, 2026, by FDA and CMS. The agencies promise a program that will deliver “life-saving Breakthrough Devices to American patients as soon as we know they work.” On its face, that is exactly what industry and patients have been waiting for.

But as with all proposals, the details matter—and here, they significantly narrow the promise.

RAPID is not a broadly applicable solution for Breakthrough Devices. Instead, eligibility is tightly constrained. For Class II devices, Breakthrough Device Designation (BDD) alone is not enough—participation in the Total Product Life Cycle Advisory Program (TAP) is also required. Class III Breakthrough Devices are not required to participate in TAP, but all devices must be subject to an Investigational Device Exemption (IDE). That requirement alone excludes non-significant risk devices, which make up the vast majority of devices on the market—particularly within Class II.

The result is a pathway that is, by design, available to only a small subset of sponsors.

Public reporting suggests that CMS estimates approximately 40 currently eligible devices, with perhaps 20 more that could become eligible. CMS has not publicly detailed how it arrived at that estimate, but given RAPID’s criteria, the pool likely consists of:

1. Class II Breakthrough Devices already in TAP that require IDE studies;
2. Class II Breakthrough Devices that could enter TAP and require IDE studies; and
3. Class III Breakthrough Devices that require IDE studies.

Even accepting that estimate at face value, the scale mismatch is striking.

As of December 30, 2025, FDA had granted 1,246 BDDs, with 185 devices having received marketing authorization. That leaves 1,061 devices with BDD that have not yet received marketing authorization. If only 40 to 60 of those ultimately qualify for RAPID, then roughly 1,001 Breakthrough Devices remain without any meaningful acceleration of the coverage pathway.

The numbers underscore a broader concern: RAPID may be less a systemic solution than a targeted pilot for a narrow slice of the market.

To be sure, the program will be valuable for sponsors that qualify. Earlier alignment with CMS and a clearer path to coverage could meaningfully reduce time to patient access for those devices. But tying eligibility to both TAP participation and IDE studies raises an important question—whether the program is built around the devices that most need coverage acceleration, or simply those that are easiest for agencies to coordinate around.

If the goal is to close the FDA–CMS gap at scale, anchoring eligibility to the Breakthrough Device program itself—rather than layering additional prerequisites—would likely have a far greater impact.

CMS is expected to issue a proposed notice in the Federal Register, triggering a 60-day public comment period. Notably, both CMS and FDA have indicated that CMS will respond to comments in the final notice, while FDA’s role in that process remains unclear.

RAPID is a step forward—but a modest one. Whether it becomes more than that will depend on how the agencies respond to stakeholder feedback in the months ahead.