FDA, CMS Unveil ‘RAPID’ to Speed Device Coverage Decisions
FDA and CMS have announced a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to reach Medicare patients, part of a broader push to streamline regulation and expand access to emerging technologies. The newly created Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway will better coordinate their review processes for certain high-impact devices, potentially reducing delays between regulatory approval and insurance coverage, according to the agencies.
The program targets devices designated as “breakthrough” by FDA — typically technologies intended to treat or diagnose serious conditions where few alternatives exist. These include certain moderate- and high-risk products (Class 2 and Class 3 devices).
Under the new pathway, the two agencies will collaborate earlier in the development process, allowing clinical evidence gathered for FDA approval to simultaneously meet requirements for Medicare coverage decisions. Officials say this alignment could eliminate redundancies that have historically slowed patient access.
“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” says CMS administrator Mehmet Oz. He added that the initiative is intended to “cut red tape” and provide faster access to “life-changing health technology” for Medicare beneficiaries.
FDA commissioner Marty Makary says the effort reflects a more unified approach across agencies. “The American people deserve timely access to meaningful treatments without red tape or high costs,” Makary adds, emphasizing that the agencies are working “as a single team” to accelerate delivery of proven technologies.
A key feature of the RAPID pathway is a synchronized review timeline. CMS said it will issue a proposed national coverage determination on the same day a qualifying device receives FDA market authorization. That move would trigger a 30-day public comment period and could lead to final Medicare coverage decisions in as little as two months — far faster than the typical process, which can take a year or longer.
To qualify, devices must be studied in clinical trials that include Medicare beneficiaries and measure outcomes agreed upon in advance by both agencies. The pathway is also tied to FDA’s Total Product Life Cycle Advisory Program for certain devices, though some high-risk products may participate regardless.
Officials framed the initiative as part of the Trump administration’s broader effort to make coverage decisions more predictable and timely for breakthrough technologies that benefit older Americans.
The announcement also signals a shift in CMS policy priorities. The agency said it will pause new entries into its Transitional Coverage for Emerging Technologies (TCET) pathway while focusing on implementing RAPID. Existing coverage mechanisms, including standard national coverage determinations, will remain in place.
A formal proposal outlining the new process is expected to be published soon in the Federal Register, followed by a 60-day public comment period before finalization.
If implemented as described, the RAPID pathway could reshape how quickly cutting-edge medical devices become available to millions of Medicare patients, while offering device makers clearer expectations for both regulatory approval and reimbursement.