Conventional Devices Deserve CDRH Attention
Looking at CDRH press, it’s hard to remember that not all devices are digital. CDRH’s 2025 annual report details digital-health milestones and the report’s “looking ahead to 2026” section highlights AI and next-generation technology. Plus, CDRH’s Digital Health Advisory Committee recently examined digital mental-health devices, CDRH and CMS launched the TEMPO pilot (speeding digital devices to market), and a new Regulatory Accelerator offers resources for digital-device innovation. For companies making catheters, orthopedic implants, and hospital beds, it’s fair to ask whether CDRH’s attention has drifted from the conventional devices on which most patients depend.
What happened?[1]
CDRH hasn’t launched conventional (non-digital) device programs to match digital ones. The disparity isn’t surprising given FDA staff cuts under the Trump administration. CDRH’s workforce dropped more than 20% last year and analysts report lengthening device review times. That’s noteworthy because CDRH emphasizes that it met MDUFA V goals, a claim in tension with analysts’ figures.
But here’s a caveat: there’s no evidence showing conventional device reviews lagging digital reviews. What’s asymmetric is CDRH attention to, and program building for, digital devices. “Attention” here means where and how CDRH deploys bandwidth – developing programs, standing up pilots, drafting guidance, and briefing the press, for example. So far, CDRH has launched digital initiatives while device review queues move uniformly. So far.
What does this mean for device firms?
The question is whether CDRH digital initiatives match device use and patient need, and the numbers aren’t encouraging. CDRH received about 22,000 device submissions in 2025 and the AI/ML device category produced around 300 510(k) clearances. That’s about 1.4 percent of the submission volume. As illustrative, the 2025 monthly clearance rate for orthopedic devices – a ubiquitous conventional-device type – was 1.5 to 2.5 times the monthly AI/ML device pace.
Patient need tells much the same story. Doctors perform about 1.5 million hip and knee replacements in the U.S. annually, along with roughly 965,000 angioplasties and 900,000 cardiac surgeries. Adding to this is more than 2 million coronary and peripheral stent implants each year. These procedures rely on conventional hardware devices.
Digital health’s reach looks different. No question, the impact is enormous – one large radiology practice, for example, reported running AI across more than 20 million exams annually. But as FDA and patient-procedure numbers show, patients face myriad illnesses, most of which require conventional devices.
None of this means that conventional devices are being shortchanged on reviews. It means that if CDRH’s limited bandwidth gets used for programs in areas representing a single-digit share of submissions, stakeholders rightly question whether enough resources remain for conventional device oversight and innovation.
What should device firms do?
First, track specific review figures instead of extrapolating from CDRH aggregates and press coverage. CDRH data includes review volumes and timelines for orthopedic, surgical, and other conventional device. Checking these numbers against digital device timelines and staffing reveals whether disparities exist.
Second, use the MDUFA VI public comment period (which closes next week) to make the innovation-versus-volume argument. Unlike prior user-fee agreements, MDUFA VI doesn’t hold FDA to specific hiring targets, opting instead for “shared intent to hire . . . additional review staff.” If digital-device hiring remains a priority (formally or in practice) while conventional-device coverage reverts to vague “shared intent” goals, that’s the moment to put patient and submission volume data on the record.
Third, don’t wait passively for CDRH support. Submission quality matters when CDRH resources are scarce. Firms competing for resources must file submissions that are well organized, well supported, and complete. CDRH would be hard-pressed to explain why it’s bypassing ready-to-go submissions in favor of digital initiatives.
Last, pay attention to CDRH’s guidance agenda. The 2026 guidance list is shorter than in past years and it carries holdover priorities like diagnostics validation and patient preference information. Even when guidance development affects conventional and digital devices alike, the impact may be greater for devices without a Center of Excellence advocating for them.
None of this is reason to panic. It’s reason to watch where CDRH’s energy and resources go. Visibility of and attention to conventional and digital devices is uneven and will remain so while CDRH resources are depleted. Firms that track product reviews, that attend to MDUFA VI hiring specifics, and that make clean submissions will be least exposed if scarce resources produce review gaps.
[1] Note: I sometimes use artificial intelligence in drafting this column. My primary tool is Claude AI. I review and verify all findings, interpretations, and final wording.