What’s Happening at CDRH? RIFs, Retirements, User Fees, and Unknowns

[Editor’s note: This article was most recently updated on May 6.]

FDA’s device center is facing steep challenges in the wake of the April 1 round of HHS “reduction in force” (RIF) notices, on top of other staff cuts and resignations that have occurred over the past three months. Morale is low, while CDRH leadership is left having to shuffle responsibilities to ensure critical statutory functions are addressed.

Conversely, some device industry advocates make the case that it could have been worse. Although some device reviewers have left, the mass layoffs did not target any reviewers, and, by multiple accounts, the drug and biologics center experienced a bigger impact from the RIFs compared to CDRH. 

It remains difficult to parse the specific implications for the medical device industry from these latest cuts, on top of all the other Trump administration actions that have impacted CDRH staffing levels and morale. To paint the clearest picture possible, here is a roundup of what we know about the people and job functions lost from CDRH, and key debates happening about the possible next shoes to drop, including risks to the user-fee programs and the prospects of a broader FDA reorganization. 

The details are based on Market Pathways reporting, including on- and off-the-record discussions with people inside and outside of FDA, and publicly available information. In multiple cases, current or recent FDA employees are quoted without full attribution based on agreements to protect their identity. We will update this article as we learn more substantive details about the new realities at CDRH.

Hundreds of CDRH Staff Gone

The Department of Health and Human Services estimated that about 3,500 FDA employees (about 18% of the agency) were targeted by the April 1 cuts, with a focus, HHS said, on “streamlining operations and centralizing administrative functions.” Impacted staffers received RIF notices immediately placing them on administrative leave and establishing a final separation date in June.

There is no official breakdown of how many people each center lost, but sources suggest that approximately 250 CDRH staffers received RIFs (although approximately 30 have, more recently, been called back – see more below). That represents about an 11% loss relative to the 2,260 employees that CDRH had at the beginning of 2025.

“I would equate it to, if you were in a bomb shelter, and you came up, and everybody was in their separate little shelters, and came up, and then was just wandering around,” relayed one former device center manager, who was spared by the RIFs only because she had already agreed to an early retirement, about the April 1 environment at FDA. “That is what it felt like. It felt like just wandering around, after a major blast. The only way to know who was there was just to walk around and ask. And that is exactly what was happening.”

The staffers who received RIFs primarily worked in administrative, communications, and policy-making functions. Industry groups tried to convey some sense of optimism, underscoring that the action didn’t target premarket device reviewers. “If it’s true that medical device reviewers and inspectors haven’t been affected, then that is good news,” said Scott Whitaker, president and CEO of AdvaMed.

Retaining reviewers is a turnaround from the Department of Government Efficiency-driven effort in February to layoff “probationary” employees, which included many reviewers and experts in areas such as artificial intelligence and cybersecurity who happened to have been hired or transitioned from fellowships recently. In response to a backlash from industry warning of the potential for patient harm, a significant proportion of the CDRH probationary staff were called back to work. But it still remains unclear, almost two months later, how many device reviewers and scientists who were dismissed in February didn’t come back to work. 

Overall Numbers Are Elusive, Even to Center Leaders

The people laid off in the April 1 RIF represent just a portion of the overall losses at the center. Many others have taken and continue to take various buyout or early retirement incentives, either via the Voluntary Early Retirement Authority (VARA), Voluntary Separation Incentive Payments (VSIP), the original Fork in the Road deferred resignation offer, or related offers.

Some have left in response to the administration’s order, which kicked in March 17, requiring employees living within 50 miles of a facility to work full-time on-site. In one case, for instance, a CDRH employee who worked from home, but recently left, was told to report to an unmanned food inspection office in Greensboro, NC, about 50 miles away from where he lived. “I was like, ‘So you want me to drive an hour every day to sit in an empty office and do virtual calls and meetings all day like I do at home and then drive home an hour?’ And they were like, ‘Yeah’,” the former employee explains. “They were trying to make it seem like it made sense.”

HHS has more recently partially walked back the return-to-office order, allowing reviewers to work remotely two days per week, according to one CDRH official who recently retired and multiple media reports.

The number of departures is growing. For instance, multiple CDRH employees worked their last day the week of April 14 to take advantage of certain retirement incentive deadlines. CDRH staffers say that even managers within the device center do not have a complete handle on the number of people who have left and the exact circumstances of their departure.

“Management tells us they don’t know how many people took VARA, they don’t know how many people took the VSIP, and they still don’t know exactly how many people took the Fork,” a one long-time CDRH staffer who recently retired tells Market Pathways. “How can you run an office if you don't know who's there?”

CDRH Director Michelle Tarver, MD, and other remaining leaders have been trying to get some of the more recently fired staff back, at least temporarily. Those efforts recently hit success in one instance: approximately 30 CDRH staffers whose job it is to respond to Freedom of Information Act (FOIA) requests were called back to work May 2, to start Monday, May 5, according to one current and one former FDA official with direct knowledge of the situation. HHS Secretary Robert F. Kennedy Jr. recently signaled plans to bring FOIA staff back amid pressure from lawmakers and at least one lawsuit. 

Where Did They Work?

HHS targeted staff from multiple sections of CDRH in the latest round of cuts. Market Pathways has been able to confirm many but not necessarily all of the impacted offices and divisions within the center.  The two largest offices impacted within CDRH were the Office of Management and the Office of Communication, Information Disclosure, Training and Education.

The Office of Management, which was staffed by upwards of 80 people and led by Janelle Barth, was completely eliminated (although one or two individual OM staffers might have been retained and reassigned, agency sources suggest). The office was in charge of financial management, budget formulation and execution, human resources, and an array of other activities. Notably for industry, the office processed MDUFA user fees and monitored user-fee metrics and spending (see more about potential implications for user fees below). It also oversaw the Small Business Determination program, reviewing whether lower-revenue companies, including start-ups, qualify for reduced user fees.

The Office of Management, which was eliminated, processed user fees, monitored user fee metrics, and, notably, oversaw the Small Business Determination program, reviewing whether companies qualify for reduced user fees.

The Office of Communication, Information Disclosure, Training and Education, led by Starlet Johnson, was also cut significantly. Specifically, OCITE leadership, in addition to staff who oversaw external and internal communications, including updating the CDRH website/intranet and crafting public safety communications, and who carried out internal CDRH training and development, including reviewer training and certifications funded by device user fees, received RIF notices. That adds up to more than 100 people who were either dismissed and a few who elected to take early retirements in advance of the RIFs. According to a supervisor within OCITE who recently left FDA who spoke on background to Market Pathways, the people in the internal training office received an extra communication, in addition to the standard RIF notice, instructing some to stay a little longer so they could hand over their work to remaining staff, particularly tasks related to device reviewer certification and the center’s “learning management system” (LMS), which tracks internal training. That hand off work was completed, the supervisor confirms, but there will be resource gaps. “There really isn’t going to be anybody to manage the LMS,” she says. “ I don’t know how they will ultimately track MDUFA training completions.” 

The FOIA team that was fired and then called back to work May 2 also sat within OCITE. In addition, one specific division of OCITE, the Division of Industry and Consumer Education (DICE), was retained. DICE oversees several well-known resources for industry, particularly small companies trying to understand regulatory procedures, including Device Advice and CDRH Learn. The division also answers calls and emails from industry (consumers in some cases) to a live CDRH helpdesk. The helpdesk is expected to stay active, although a former manager from OCITE suggests it may be awhile before the resource sites are updated, as the staff who updated all the webpages are gone.

[Corrections: We have increased the number of employees from OCITE identified as receiving RIFs compared to a prior version of this article, based on additional information from impacted staff. Also, an earlier version of this article incorrectly stated that CDRH communications staff drafted 510(k) summaries. Manufacturers write 510(k) summaries and reviewers ensure their accuracy. Communications staff post the summaries online.]

The smaller, but impactful Office of Regulatory Programs was also eliminated, although the four ORP subdivisions (Submission Support, Establishment Support, Surveillance Support, and Regulatory Systems, Tools, and Data Management) that are listed separately in CDRH’s organizational chart were retained. ORP provided programmatic support for the Office of Product Evaluation and Quality (OPEQ), where all the product-specific review, surveillance, and compliance divisions reside. It helped manage many functions of the MDUFA user-fee program, develop policy interpretations and analysis for OPEQ, and its leaders played a significant role in user-fee negotiations with industry. Significantly, ORP was led by respected CDRH veterans, including Director Sean Boyd and Deputy Director Barbara Zimmerman, who each had worked at the center for more than 30 years, and Deputy Director Mike Ryan, who had been there for more than 20 years. OPEQ’s Operations staff, which primarily handled HR-related issues, was also largely eliminated.

In addition, the Division of Health Equity (DHE) within the expansive Office of Strategic Partnerships and Technology Innovation (OST) was shut down. DHE, with just eight staff members (including six that were RIFed and two who recently retired) managed an array of cross-cutting programs, including Small Business Innovation Research (SBIR) grant reviews, a payor feedback, start-up engagement, and efforts to improve medtech innovation in pediatrics and women’s health. The immediate office that DHE reported up to, the Office of Equity and Innovative Development (OEID),  headed by Terri Cornelison, MD, PhD, was also shut down. (See HHS Shutters Device Unit Supporting Start-ups, Pediatrics, and Women’s Health,” Market Pathways, May 1, 2025.)

Key Staff Departures

Notably, Tarver and Richard Pazdur, MD (director of the Oncology Center of Excellence) are the only two permanent center directors who have remained in place throughout the disruptions during the past three-plus months. FDA has installed acting directors to lead the centers for drugs, biologics, and veterinary medicines, and there is currently no director listed for the tobacco products center.

Tarver’s presence may be providing some level of stability. She was elevated to the CDRH director role last October (following Jeff Shuren’s retirement), but she’s worked at the device center for more than 15 years. “Michelle’s looking out for us,” said the long-time CDRH staffer who recently left the agency. “She's trying. She's got a lot of loyalty to the people around her, because she used to be one of us.”

In addition to the directors of eliminated departments, several other key CDRH leaders are no longer working at the center. Douglas Kelly, who was deputy center director for science, left in March, agreeing to a deferred resignation incentive. Kelly spearheaded CDRH’s TPLC Advisory Program and he recruited an array of employees to FDA with non-traditional backgrounds to help advise TAP companies on topics like reimbursement, manufacturing, and commercial considerations. Most of the TAP advisors remained with FDA, at least in the wake of the April 1 RIFs, although at least one, Julius Torelli, MD, a cardiologist and value-based care/reimbursement expert, has recently left.

Troy Tazbaz, who was running the Digital Health Center of Excellence, left the agency in late January, and has since returned to a senior VP role at Oracle, where he worked before joining FDA.

Another significant loss is Ross “Rusty” Segan, MD, who joined FDA as head of OPEQ, overseeing all review offices, last September. Segan, a surgeon who has served as chief medical officer for multiple device companies, was caught up in the February 15 cuts of probationary workers. Even though many of those cuts were reversed, Segan has not returned to the agency. Owen Faris, deputy center director for operations, has stepped in as acting director of OPEQ, a post he filled before Segan was hired.

The most pressing question for some industry players, however, centers around the state of mind of the remaining reviewers and scientists who work deeper down within OPEQ. The eight Offices of Health Technology, which house all the reviewers and product-specific surveillance and enforcement staff, are, by several accounts, largely intact. However, some reviewers and review managers have started to leave.

For instance, Malvina Eydelman, MD, a 30-plus year CDRH veteran and long-time head of the office that reviews ophthalmology and ear, nose, throat (ENT) devices left FDA in March and recently took a post as the CEO of the Collaborative Community of Ophthalmic Innovation. Another example is Michael Bailey, PhD, who worked at CDRH for more than 20 years, most recently as a team lead for OB/GYN device reviews, and retired April 19. Quentin Moore, PhD, an AI/ML expert and lead reviewer in the imaging device division, who was originally impacted by the February probationary employee terminations announced April 28 that he was hired as director of regulatory affairs for the clinical AI device firm Aidoc.  

Whether current morale and stability issues lead to a bigger mass exodus remains to be seen. There is also the possibility that the administration could pursue more layoffs or other reductions.

Short-Term Contracts, Recusals Drives Instability 

One specific issue cropping up that appears to be driving more scientists to leave or at least consider leaving FDA is HHS’ recent approach with renewing contracts. One common CDRH hiring route for Ph.D. scientists is via Title 42, which provides a more flexible, streamlined mechanism for the agency to hire highly qualified scientists. It’s a mechanism that has been used, for instance, to bring on many AI and cybersecurity experts with CDRH’s Office of Science and Engineering Laboratories (OSEL). Many of those individuals perform expert consults on premarket device reviews while also performing regulatory science research. 

Title 42 fellows are typically hired under a three-to-five year contract, which can be renewed, often for a similar period. But, recently, employees coming up for an extension are being offered much shorter terms, in the range of two-to-five months, according a current CDRH scientist, as well as a device consultant who works directly with FDA. “This level of instability is pushing many scientists to leave the agency and look for jobs in industry or elsewhere,” the CDRH scientist, with colleagues who have been offered unexpectedly short extensions, told Market Pathways, on the condition of  anonymity. “It’s hard for anyone to feel secure with only a short term extension.”

The staffer estimates that about 20% of people working in her specific division have recently resigned. A consultant and former FDA staffer said that, as of several weeks ago, two of his colleagues still at the agency were actively looking “because their contracts were only extended to June or July.” 

Another prevalent issue is the predicament of reviewers who must declare a conflict of interest, and not work on certain submission files, because of companies they are interviewing with in pursuit of a job outside of FDA. “Reviewers and compliance officers … can’t work on many of the products in their area, they can’t even be assigned new products coming in, if they are looking for a job, because they have to disclose they are looking for a job,” said a long-time CDRH manager who recently left in the context of an early retirement incentive. “That is going to impact their ability to assign new work.”

Review Impacts Coming?

Even though reviewers have largely been spared, device companies pursuing submissions with the agency are still likely to be impacted in the near-term, FDA watchers warn. Many staffers hit by the RIFs, for instance, provided direct or indirect administrative support for the review program, and their absence could restrain the premarket process in unpredictable ways. 

“If you've got a review team of five people and you've got one administrative person who's assigned to that team, who historically has been the point of contact for the regulated entity who helps manage those communications, who helps set meetings, who takes the meeting minutes, who does all the administrative support, that's just a necessary part of the job,” Michael Gaba, vice chair of the law firm Polsinelli’s food and drug practice, noted in an interview. With the RIFs, now someone on the review team will likely need to spend time on these tasks, “which will invariably slow down the review process,” Gaba suggested. “I think industry needs to be prepared to see deadlines slip.”

It is not fully clear whether reductions at CDRH have yet to lead to any systematic delays in device reviews. By and large, review teams are maintaining meeting and response timelines, according to regulatory consultants and device executives. “I have not heard any of the board members talking about a remarkable delay on time to market,” said Robert Cohen, Stryker’s president of digital, robotics, and enabling technology, referencing AdvaMed’s Digital Health Tech board of companies developing software-based devices, during an April 22 media briefing on the trade association’s AI policy priorities. 

But tangible impacts on the review process are beginning to be observed. Jonathan Kahan, a veteran regulatory device attorney and partner at the firm Hogan Lovells, said his firm meets every Monday to discuss casework and clients, which include 1,200 device companies. It’s clear from those debriefs that companies are starting to hit some slowdowns, he suggested during an discussion on an episode of the FDA Watch podcast, posted April 28. “We are seeing delays in Pre-Submissions. We are seeing delays in [additional information] letters. We are seeing delays in De Novo reviews, PMA reviews, 510(k) reviews,” Kahan said on the podcast. “Right now, it is too early to tell in the long term. But in the short term, we are seeing delays and some confusion on the part of the different reviewers and supervisors within CDRH.”

Attorneys and consultants who work closely with the device center say they expect the Pre-Submissions Program, where companies can seek early input on development plans, to be most impacted in the near term. Pre-Submissions are “very very time consuming, and the number of Pre-Submissions have gone up dramatically over the last few years” said Daniel Schultz, a principal at the consultancy Eliquent and the former director of CDRH, who appeared with Kahan on the podcast. “I don’t think the agency is going to have enough people to support them.” 

More broadly, experts say reviewers may need to interact less with companies. Typically, reviewers can send informal emails, for instance, to address some lingering questions for sponsors. Instead, if pressed for time, they may need to issue more formal “disapprovals” requiring firms to resubmit applications after addressing FDA-identified shortcomings, consultants suggest. (See “5 Tips for Dealing With the DOGE-Era FDA,” Market Pathways, March 24, 2025.) This challenge is already being felt with some investigational device exemption (IDE) clinical trial submissions. One consultant relayed that a client’s IDE recently received a disapproval “that could have been averted (and approved) if FDA was not hindered in managing some questions interactively.”  

User Fees in Peril?

There has also been growing public discussion about the prospect of a more fundamental threat to the FDA review program if the cuts undermine the agency’s ability to collect industry user fees. The possibility was advanced in an analysis posted April 3 by Politico’s AgencyIQ, warning, based on input from FDA officials, that the user-fee programs are in “extreme jeopardy.” And reporting by Market Pathways confirms this is a legitimate worry held by officials inside FDA and legal experts who engage with the agency.

It’s a “very real fear that we need to understand,” said Philip Desjardins, a partner at Arnold & Porter who previously served as a policy staffer and regulatory counsel at CDRH and a regulatory affairs VP at Johnson & Johnson. “But I don't want to make too big of an issue out of it. I do think there's time and there are things that could be done to continue to keep those doors open.”

The device user-fee program (MDUFA V, in its current iteration), according to both industry and FDA, has helped underpin significant strides in the predictability, transparency, and efficiency of device reviews. But user-fee law also contains provisions intended to ensure that industry isn’t expected to fund too much of the agency’s budget. For FDA to collect fees, the statute requires that Congress appropriate funding above an annually calculated minimum amount. A second trigger in the law requires that FDA spend above a certain threshold of the congressionally appropriated money on premarket review and related expenses. Even though the layoffs didn’t target user-fee funded reviewers, the big drop in overall spending threatens FDA’s ability to meet that second trigger.

In fiscal year 2024, for instance, FDA spent nearly $280 million of congressional money on the “review of device applications plus certain other costs,” clearing the $240.9 million threshold that was set for that year by $40 million, according to the agency’s most recent MDUFA V financial report to Congress. 

“Don’t get me wrong, $40 million is a big number,” Desjardins explained. But “$40 million can be spent or not spent very quickly, and if you think about reducing your staff by 200 to 400, I think you reach the $40 million threshold pretty quickly.” The trigger mechanisms are similar for other FDA user-fee programs, including for pharmaceuticals, but the calculations will be different.

The problem should be solvable, Desjardins and others stress. FDA can try to direct the money in a strategic way to maximum user-fee-related activities. Industry can also try to work with Congress to enact a temporary waiver or adjustment of the trigger mechanism.

One major barrier to solving the issue or even clarifying whether there is a problem or not is that the people charged with tracking spending and calculating where funds should be directed to ensure the trigger is met have lost their jobs. In addition, it is not clear to what extent the administration and Secretary Kennedy want to see the user program continue. Kennedy has suggested that FDA is “captured” by industry, and advisors to the secretary have explicitly pointed to the user-fee programs as a source of potential corruption.

Anybody at the Negotiating Table?

Even if fee collection can continue, there are real questions in play about what steps will be taken to continue MDUFA and other FDA user-fee programs after they are set to expire in September 2027. FDA and industry groups had previously been expecting to kick off negotiations on agreements to reauthorize the programs this summer. But most parties no longer expect that to happen, particularly considering that many key people involved in constructing and negotiating user-fee packages are no longer employed by the agency.

“I think there is going to be a delay,” said Desjardins, who has participated either on the FDA or industry side of the negotiations for the past three (III-V) MDUFA programs. “There is going to be a lack of people inside FDA who understand how this process works.”

And, of course, it is not clear that the administration will want to engage in negotiations. If they do, Gaba pointed out, it’s evident that the administration wants political appointees and not career government officials leading any policy development. “I think the signals have been very clear that we should expect that the negotiation on the government side is going to be handled by people in HHS' leadership or the White House,” he said. “It's an opportunity for industry to explain very clearly to this administration the value of the user-fee program for the US to remain a leader in innovation and being first to market.”

One potentially positive development for the prospect that FDA will engage in user-fee negotiation is the agency recently tapped Grace Graham as deputy commission for policy, legislation, and international affairs. Graham previously served as the top Republican health staffer on the House Energy and Commerce and Senate Health, Education, Labor, and Pensions Committees, where she has been integrally involved in previous user-fee reauthorization efforts.

Makary Says No to Complete Reorganization

The other potential action that stakeholders are worries about is a significant organizational restructuring at FDA. HHS has cut thousands of people, but leaders have yet to officially announce any updates to the agency’s organizational structure.

A memo sent by HHS to lawmakers in April on reorganization plans references a proposal to “streamline the FDA to remove unnecessary management layers and offices and streamline them into five shared offices.” A separate document that has been circulating, though its origins remain less clear, outlines five potential cross-agency offices. It would include one office to centralize all product reviews (device, drug, etc.) under one Product Evaluation and Regulation Office, and separate FDA-wide offices for inspections, compliance, and enforcement; administrative and shared services; scientific and regulatory policy; and strategic programs and innovation.

However, FDA Commissioner Marty Makary recently stated that a major reorganization was not being planned for FDA. “There will not be a reorganization,” Makary said in an April 28 interview with Jeremy Faust, MD, for Inside Medicine and MedPage Today. “Yes, we are consolidating travel offices, IT, and some other things that make sense for efficiency, but nothing else is planned. A proposal for a reorganization came from some staff, but I rejected that proposal. I said that we will work within the existing structure. We are going to focus on making the FDA a great place to work. Reviewing applications is hard work. Our staff deserve a great place to work.”