CMS and FDA Announce Expedited Pathway for Approval of Medical Devices

The new pathway is meant to get medical devices to patients sooner, especially those that target heretofore unmet medical needs.

Matt MacKenzie

April 23, 2026

Key Highlights

The RAPID pathway facilitates early collaboration between FDA and CMS to align evidence requirements for device approval and coverage.
It targets breakthrough devices that meet unmet medical needs among Medicare beneficiaries, including certain Class II and all Class III devices.
Eligible devices must be under an Investigational Device Exemption (IDE) study and may participate in the FDA TAP program.
CMS continues to offer multiple pathways for device coverage, including standard processes for national coverage determinations.
The initiative aims to significantly reduce delays between FDA market authorization and Medicare coverage decisions.

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CMS and FDA have announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which is “designed to expedite access to certain FDA-designated Class II and III Breakthrough Devices for people with Medicare.”

The RAPID coverage pathway allows “CMS and the FDA to work together, with innovators, earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions. By aligning regulatory and coverage expectations in advance, the RAPID coverage pathway is designed to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations.”

It is specifically meant for “breakthrough devices that address unmet medical needs among Medicare beneficiaries and is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of whether they are participating in TAP.” Devices must be subject to an Investigational Device Exemption (IDE) study.

CMS will “continue to offer multiple pathways to support access to medical technologies, including the standard process for opening, deciding, or reconsidering national coverage determinations.”