I usually begin these predictions with a self-congratulatory review of the previous year’s guesses. My choice of topics with clear trajectories is impressive (I took Olympic gold in cherry picking).
But joking while the new Trump administration threatens to dismantle the US Food and Drug Administration (FDA) seems tone-deaf, so this year I’m changing up a bit. Yes, I’ll review my 2024 predictions, but even with time for self-congratulation, I’ll finish quickly and focus on 2025.
Here are my 2024 predictions:
Diagnostics Regulation Will Stall
After the VALID Act (which clarified the FDA’s authority to regulate lab-developed tests [LDTs]) died on the vine in Congress, the FDA decided to go it alone, publishing an LDT regulatory framework. I predicted that, with adverse parties lining up to sue FDA, LDT regulation wouldn’t see daylight in 2024. I was right. Given the incoming administration, it’s unlikely that FDA LDT regulation will ever get off the ground – more on that later.
CDRH Digital Activity Will Grow
Calling this prediction low-hanging fruit would require me to level up (a lot). To make it more challenging, I forecast two developments: (1) Predetermined Change Control Plans (PCCPs), which allow device changes without prior regulatory review, would expand, benefiting digital devices; and (2) digital innovation would stay within FDA regulatory bounds. The FDA released its PCCP guidance for AI-enabled device software in December, noting that established law allows it. Expanded PCCP use? Check. Traditional authority? Check.
Real-World Evidence Won’t Be Ready for Prime Time
Everybody thinks that real world evidence (RWE) is a good idea, but device review using RWE alone is a non-starter while problems with data reliability, generalizability, and applicability persist. I correctly predicted that the FDA’s Center for Devices and Radiological Health (CDRH) wouldn’t crack this nut in 2024. Clinical evidence remains the gold standard and a must for device approval.
Aligning the Device Quality System Regulation With ISO 13485:2016
Last February, CDRH finalized the Quality Management System Regulation (QMSR), which harmonizes FDA’s Quality System Regulation with international quality standard ISO 13485:2016. A big question was when the QMSR would take effect. I cautioned that FDA’s one-year rollout plan might stick, but I was wrong. Pressured by stakeholders, CDRH extended the go-live date to February 2026.
Remote Device Inspections Won’t Take Hold
I like remote device inspections. CDRH (mostly) doesn’t. Nothing’s happening here.
My 2025 Predictions
RFK Junior Will Be the Next HHS Secretary (Probably) and Marty Makary Will Be the Next FDA Commissioner
Let’s talk first about Robert F. Kennedy Jr. A few weeks back, I would’ve called him a shoo-in. But now I’m not so sure. If the Senate votes along party lines, Kennedy’s approval margin is razor-thin. He can afford to lose only three Republicans and there’s a rising tide of opposition. More than 15,000 doctors recently signed a letter opposing Kennedy’s confirmation, telling senators that his nomination was appalling.
Still, what does Kennedy’s confirmation mean for CDRH? No doubt, it’s bad news for the FDA generally. We’re already seeing the exodus of senior leaders like Principal Deputy Commissioner Namandjé Bumpus and CDER Director Patrizia Cavazzoni. Even Kennedy’s ostensibly “good” ideas have a weird twist, like using nutrition to promote raw milk. And that’s leaving aside how his anti-vax mania threatens FDA’s biologics center.
The good news is that none of this directly impacts CDRH. The device center isn’t on Kennedy’s radar, and even high-profile issues seem not to spur his interest. His Eye of Sauron may eventually turn to CDRH, but until then, the device center’s best strategy is to lay low.
None of my snark extends to Marty Makary, the surgeon and Johns Hopkins University professor slated to be FDA’s next Commissioner. As I’ve recently written, Makary is a respected doctor and academic. Even those opposed to Makary’s views agree that he’s qualified to lead FDA.
And Makary’s disruption bias could benefit CDRH. His publications and public statements highlight systemic flaws and better ways to get things done. This syncs with CDRH’s embrace of new approaches where old models don’t work. An example is regulation of digital devices. CDRH is developing new tactics for technologies that evolve so quickly that traditional approaches like prior review are unfit. Like departing Commissioner Robert Califf, CDRH may spur Makary to endorse streamlined regulation. FDA’s pro-innovation alignment with industry makes this an even lighter lift.
FDA Will Not Regulate LDTs
I’ll say this clearly (with steak sauce in case I eat these words): No way does FDA regulate LDTs. Whoever the next HHS Secretary is, and with the best-possible view of Marty Makary, the new administration is going back to where it was on LDTs: keeping LDT regulation out of FDA hands.
That’s the position that the first Trump administration took. The Biden administration swiftly re-asserted FDA’s LDT authority. Failed legislation, attempted regulation, and lawsuits followed (discussed above). The next HHS Secretary will restate that FDA does not regulate LDTs, taking us right back to pre-Biden 2021. Regulatory Chutes and Ladders anyone?
CDRH Will Continue Business as Usual
Before and after his reelection, Trump promised to resuscitate Schedule F, a federal jobs provision making it easier to purge career employees. RFK Junior doubled down, warning FDA staff to “preserve your records and pack your bags.”
Now Trump and Kennedy must govern (not get elected), and if their first step is to eviscerate career staff, good luck with that. More importantly, CDRH is probably outside their blast zone. This leaves the device center with core responsibilities – things like premarket product review, stakeholder oversight and engagement, and device quality review. In this administration, the last one, and the ones before that, device makers were required to meet safety, efficacy, and quality requirements. Those requirements aren’t driven by who sits in the White House or who runs HHS.
One caveat: CDRH staff morale will suffer. It’s naive to tell staff to keep their heads down while facing rants about their failings. Without relief, top-level departures may sweep up career staff, and that will impair core CDRH operations.
Digital Device Regulation and RWE Will Flourish
This prediction is a lob at the net. As I’ve written, CDRH spots and adapts to changes affecting devices. This includes revising regulatory frames when old models don’t fit new technologies and miss relevant data.
RWE and digital devices exemplify this. RWE uses new data sources (like registries and billing records) to show device safety and efficacy and post-market effect. Digital devices use technologies like software and artificial intelligence to deliver care. Both RWE and digital devices require FDA to work differently. For example, traditional regulations require device design to be “locked” after agency review, meaning that the design stays fixed after the device comes to market. But digital devices iterate, and locking their design hampers this evolution. Recognizing this, CDRH has adjusted digital design requirements to allow ongoing changes.
There are myriad examples of CDRH’s pro-innovation stance, from creating the Digital Health Center of Excellence, to the Predetermined Change Control Plan guidance, to the Breakthrough Devices Program. But really, the reason that RWE and digital devices will grow is that they’re good for business. Industry supports and informs the changes that CDRH makes to foster digital devices and RWE. The incoming administration wants the government to promote business, and CDRH programs hitting that mark will thrive.
There’s an old saying, “May you live in interesting times,” where “interesting” means trouble. It seems like CDRH’s 2025 will be interesting to say the least. That’s a dire note to end on, so I’ll close instead by wishing you all an uninteresting new year.
Steve Silverman is the president of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Steve’s professional experience includes extensive time in senior FDA roles. At the FDA, Steve directed the CDRH Office of Compliance, where he led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganization.