FDA Commissioner Makary Resigns: Leadership Crisis, Workforce Collapse, and What It Means for Medical Device Regulation in 2026

The Departure

On May 12, 2026, Dr. Marty Makary resigned as FDA Commissioner after just 13 months in the role. His departure, which multiple reports indicated came after President Trump had signed off on a plan to dismiss him, triggered an immediate and cascading leadership vacuum across the agency's drug, biologic, and device centers -- one that is still unfolding as of this writing.

President Trump, when asked about the situation, offered a response that did little to clarify the administration's position: "I've been reading about it, but I know nothing about it." Health and Human Services Secretary Robert F. Kennedy Jr. struck a more diplomatic tone, praising Makary's service and noting that a "search for a new Commissioner is already underway."

Kyle Diamantas, who had been serving as deputy commissioner for food, was named acting commissioner. Diamantas is a lawyer by training and does not hold a medical degree -- a notable departure from the professional profile typically expected of FDA commissioners, who have historically been physicians or scientists with deep regulatory experience.

For medical device manufacturers, Makary's departure is not an isolated event. It is the culmination of a 12-month period in which the FDA has endured unprecedented workforce reductions, serial leadership turnover across every major center, measurable degradation in review capacity, and growing anxiety across the regulated industry about whether the agency can fulfill its statutory obligations under MDUFA V. This analysis examines what happened, what it means for device review timelines and regulatory strategy, and what companies should do now.

Why Makary Left: The Reported Factors

Multiple media outlets and sources within HHS have reported on the circumstances leading to Makary's resignation. While the full picture remains incomplete, several consistent themes have emerged:

Clashes with the White House over policy priorities. Makary, a surgeon and public health researcher at Johns Hopkins before his appointment, reportedly found himself at odds with the administration on multiple fronts. These tensions predated his confirmation and intensified during his tenure as the White House pursued an aggressive deregulatory agenda that sometimes conflicted with the FDA's traditional evidence-based approach.

Internal disputes over drug approvals. Several reports cited friction between Makary and political appointees over the pace and standards for drug approvals, including pressure to accelerate authorizations that career staff considered insufficiently supported by clinical data.

The e-cigarette dispute. One specific flashpoint involved the FDA's authorization of fruit-flavored e-cigarettes. Makary had reportedly opposed these approvals on public health grounds, particularly regarding youth appeal, but the agency proceeded with the authorizations anyway -- a decision that signaled his limited authority over the agency's direction.

Mifepristone review delays. Anti-abortion groups had expressed anger over the pace of the FDA's review of mifepristone-related regulations, and this political pressure created additional strain on the commissioner's position.

Whatever the precise weighting of these factors, the practical reality is that Makary presided over what many observers now regard as the most damaging period in FDA history from a workforce and institutional capacity standpoint -- even if the policies driving that damage originated above him.

The Cascading Leadership Collapse

Makary's resignation did not occur in a vacuum. It was the capstone on a period of extraordinary leadership instability that had already destabilized the agency. Within days of his departure, the leadership exodus accelerated.

Center for Drug Evaluation and Research (CDER)

CDER has been in a state of near-continuous leadership crisis since mid-2025. The center has now gone through five leadership changes in less than a year:

Five leaders in twelve months is not turnover -- it is institutional hemorrhage. CDER is responsible for overseeing the safety and efficacy of all prescription and over-the-counter drugs in the United States. It is the largest and arguably most consequential center at the FDA. Its current acting leadership inherited an organization that has lost thousands of staff and is operating without confirmed, stable leadership.

Center for Biologics Evaluation and Research (CBER)

CBER, which oversees vaccines, blood products, gene therapies, and biologics, has faced its own leadership turmoil:

• Vinay Prasad served as CBER director from May 2025 to April 2026, when he stepped down amid a toxic workplace investigation. His tenure was marked by significant internal controversy and staff dissatisfaction.
• Katherine Szarama stepped aside as acting director following Makary's resignation.
• Karim Mikhail has since taken over as acting CBER director.

CBER's instability has particular implications for manufacturers of combination products, cell and gene therapies, and IVD devices that are regulated as biologics. The center's review capacity for novel biologics and gene therapies -- already strained by the complexity and volume of submissions -- is now further compromised by leadership uncertainty.

Other Key Departures

Beyond the center-level leadership vacancies:

• Chief of Staff Jim Traficant was removed from his position, though he remains at the agency in an advisory capacity.
• Lowell Zeta was named acting chief of staff.
• Senior departures from the Digital Health Center of Excellence and the Office of Neurological and Physical Medicine Devices have been reported, further depleting institutional knowledge in areas critical to innovative device review.

As of May 20, 2026, every major FDA center is operating under acting leadership. There is no confirmed commissioner. There is no confirmed center director at CDER, CBER, or CDRH. The agency is, in a very real sense, running on autopilot.

The Workforce Collapse

The leadership crisis is severe, but it is the workforce losses that pose the most direct threat to medical device review capacity. The numbers are stark.

The Scale of the Cuts

• 3,500 FDA positions were eliminated in 2025 as part of HHS-directed reductions in force -- approximately 19% of the agency's total workforce.
• The FDA lost a net 3,870 employees in FY2025, with an additional 587 departures in FY2026 as of January data.
• CDRH, the Center for Devices and Radiological Health, lost 230-250 staff in what industry observers have termed the "February purge" -- a mass layoff event that disproportionately affected scheduling and administrative support personnel, communications staff, and the infrastructure around device reviewers, even though formal reviewers themselves were not directly cut.

The Measurable Impact on Device Review

The workforce losses have already produced measurable degradation in FDA's device review output:

• High-risk device approvals fell to a 10-year low in Q1 2025, with just 9 approvals compared to 13 in Q4 2024 and 14 in Q1 2023. This decline occurred during the period when the cuts were being implemented and before their full effects had propagated through the review pipeline.
• 111 Class I recalls and early alerts were issued in 2025 -- the most serious recall category, driven by sterilization failures, packaging defects, and inadequate instructions. Whether this spike reflects degraded manufacturing oversight, reduced FDA inspection capacity, or other factors is difficult to disentangle, but the number is concerning.
• Reviewers are juggling multiple roles, filling in for departed senior leaders without adequate support staff. At MedCon 2026, CDRH official Barb Marsden acknowledged that staffing shortages were causing real delays in device review -- a rare public admission of operational strain from within the agency.

The Kezar Life Sciences Case

The human cost of FDA capacity constraints is not abstract. Kezar Life Sciences, a clinical-stage biopharmaceutical company, collapsed in 2025 after its scheduled Type C meeting with the FDA was cancelled without explanation and rescheduled months later. By the time the meeting finally took place, the company had already cut 70% of its staff. While Kezar operates in the drug space rather than devices, the case illustrates what happens when FDA engagement becomes unreliable -- small and mid-sized companies with limited runway simply cannot survive extended periods of regulatory uncertainty.

The Rehiring Effort

In what many observers have interpreted as a tacit admission that the cuts went too far, the FDA is now actively trying to hire back more than 3,200 people by mid-2026. The rehiring effort is itself complicated by the fact that the agency's reputation as a stable employer has been damaged, and many of the most experienced career staff who departed have moved on to positions in industry, consulting, or other government agencies. Rebuilding institutional knowledge takes years; losing it takes months.

BioCentury characterized the overall pattern as a "slow-moving catastrophe" -- a description that, while dramatic, reflects the growing consensus among industry analysts, former FDA officials, and regulatory professionals that the agency's capacity has been fundamentally and perhaps durably compromised.

The Paradox of MDUFA V Performance Metrics

Here is the situation's central irony: on paper, FDA's formal MDUFA V performance metrics are still being met. Median 510(k) clearance times in early 2026 actually look slightly better than 2024 numbers. PMA decision times remain within the statutory windows. The agency's user fee performance reports tell a story of operational continuity.

But the formal metrics tell an incomplete story. The experience on the ground, as reported by device sponsors, regulatory consultants, and industry groups, is markedly different from what the performance data suggests.

What the Metrics Miss

Pre-submission meeting scheduling is strained. Companies report longer wait times for pre-submission (Q-submission) meetings with CDRH, and in some cases, meetings are being rescheduled or handled by less experienced staff. Pre-submission meetings are one of the most valuable tools available to device manufacturers -- they provide early feedback on study design, testing requirements, and regulatory pathway selection. When these meetings are delayed or staffed by reviewers without deep experience in the relevant clinical area, the quality of feedback suffers, and downstream submission quality may be compromised as a result.

Informal feedback channels are degraded. Historically, device sponsors could often obtain informal guidance from FDA reviewers on study design questions, protocol modifications, or submission strategy through interactive review correspondence and supplemental information exchanges. With reviewers stretched thin and covering expanded portfolios, this kind of responsiveness has diminished. The FDA Group, a regulatory consultancy, has reported that some applications appear to be "idling" -- moving through the system without the kind of active engagement that typically characterizes productive FDA-sponsor interactions.

Reviewer expertise has been diluted. When senior reviewers and branch chiefs depart, their portfolios are redistributed among remaining staff who may not have the same depth of experience in the specific device type or clinical area. This does not necessarily produce longer review times on the clock, but it can produce lower-quality review correspondence, more rounds of questions, and less helpful feedback -- all of which extend the effective time from submission to clearance or approval.

There is a "general sense of hesitancy and uncertainty" among device sponsors, as reported by multiple trade publications and regulatory consultancies. Some companies are delaying submission timelines not because their products are not ready, but because they are uncertain about the regulatory environment they are entering. This hesitancy is itself a cost -- it delays patient access to new devices and extends the period during which companies must sustain development programs without revenue from the US market.

Why Smaller Companies Are Disproportionately Affected

Larger device manufacturers with experienced internal regulatory affairs teams, established relationships with FDA reviewers, and the financial resources to absorb delays can weather this period of instability. Smaller companies and startups cannot. They are more dependent on pre-submission meetings, more sensitive to review timeline extensions, and less able to maintain the cash runway needed to survive unexpected delays. The Kezar Life Sciences example, while from the drug side, illustrates a pattern that device companies should take seriously.

Industry and Analyst Reactions

The reaction from industry analysts, trade associations, and regulatory observers has been unusually pointed:

Capital Alpha Partners: "Makary oversaw what must be the most damaging period in FDA history." This assessment, from a firm that provides Washington policy analysis to institutional investors, reflects the financial community's growing concern about FDA stability as a risk factor for biopharma and medtech investments.

Truist Securities: "In a protracted scenario without formal leadership, we'd expect more delays and unpredictability." The conditional framing acknowledges that the current situation could stabilize quickly with the appointment of a qualified commissioner -- or could deteriorate further.

RBC Capital Markets (Brian Abrahams): Continued lack of steady leadership challenges "investability across the biopharma ecosystem." This is Wall Street language for a serious problem: if investors cannot predict when or whether FDA reviews will be completed on a reasonable timeline, capital allocation decisions become harder, and the entire pipeline of innovation from startup to commercialization slows.

BIO (John Crowley, CEO): "We need organizational strength and stability at the agency. It is time to right the ship." BIO is the biotechnology industry's largest trade association. Its decision to call explicitly for organizational repair at the FDA signals the severity of the situation from the industry's perspective.

Lisa Voronkova (Ova Solutions, writing for MD+DI): "Makary's exit won't solve medtech's biggest issue: the February purge of 230 CDRH staff did more damage to device review than any commissioner ever could." This observation gets to the heart of the matter for device companies. The commissioner is important, but CDRH's operational capacity -- the reviewers, compliance officers, and support staff who actually process 510(k) submissions, evaluate PMA applications, and conduct facility inspections -- is what determines whether the device review system functions.

Reuters: The departure may temporarily lift biotech sentiment but "FDA leadership vacuum looms." The news agency's framing captures the paradox: the market may react positively to the removal of a controversial figure, but the underlying institutional damage remains.

Timeline of Key Events

For reference, here is a chronological summary of the major FDA leadership and workforce events since mid-2025:

What This Means for Medical Device Manufacturers

The operational implications of the FDA's current state are significant, even if they have not yet manifested as dramatic changes in published review timelines. Here is what device manufacturers should expect and prepare for.

Near-Term Expectations

Acting leadership at every level means institutional caution. When senior officials are serving in acting capacities, they tend to be more risk-averse. Decisions that require judgment calls -- such as accepting alternative testing approaches, agreeing to modified clinical endpoints, or exercising enforcement discretion -- may be deferred or subjected to additional layers of review. This does not change the formal regulatory requirements, but it changes the practical experience of interacting with the agency.

No formal changes to review procedures or timelines have been announced. As of this writing, the FDA has not issued any public statements indicating changes to review procedures, acceptance criteria, or statutory timelines for device submissions. The MDUFA V performance commitments remain in effect. Companies should not assume that formal requirements have changed -- but they should be prepared for less responsive and less predictable interactions.

Pre-submission meetings may be harder to schedule and less productive. The pre-submission (Q-submission) process remains operational, but companies should expect longer lead times for meeting scheduling and the possibility that meetings will be staffed by reviewers who are covering unfamiliar device types. To compensate, companies should provide more detailed and well-organized meeting packages that reduce the need for extensive reviewer preparation.

Informal feedback channels are strained. The kind of rapid, iterative feedback that experienced regulatory teams have historically relied upon -- supplementary information exchanges, informal telephone conferences with branch chiefs, quick clarification emails -- is less available. This means that companies need to be more self-sufficient in their regulatory strategy development and less reliant on FDA feedback to resolve ambiguous requirements.

Inspection scheduling and conduct may be affected. With the loss of investigators and compliance staff, routine surveillance inspections may be less frequent, but when they occur, they may be conducted by inspectors who are less familiar with the specific device type or manufacturing process. Companies should ensure that their quality management systems are audit-ready at all times and that they can clearly articulate their compliance with QMSR requirements to any inspector, regardless of the inspector's familiarity with their technology.

Strategic Recommendations

1. Ensure submissions are as complete as possible on first submission.

This is always good practice, but it is now critical. With reviewers stretched thin, the tolerance for incomplete submissions, missing data, or poorly organized documentation is lower than ever. A submission that generates multiple rounds of additional information requests will take longer to resolve -- not because the formal review clock has changed, but because the reviewer's capacity to process each round of correspondence is constrained.

Practical steps:

• Conduct a thorough internal review of every submission before filing, including a mock review by someone not involved in the preparation.
• Ensure all testing reports, clinical data, and labeling documents are complete and cross-referenced.
• Address potential reviewer questions proactively in the submission cover letter or summary documents.

2. Pursue parallel regulatory strategies where feasible.

Companies that are pursuing market access in multiple jurisdictions should consider whether their EU MDR, UK MHRA, Health Canada, or TGA submissions can proceed on timelines that are independent of their FDA strategy. If FDA interactions are delayed or unproductive, having parallel regulatory programs in other markets can provide revenue and momentum while the US submission progresses.

3. Maintain QMS readiness at all times.

The transition to QMSR is now in effect, and FDA inspections are being conducted against the updated framework. With inspection capacity strained, companies should not assume that a period of reduced inspection frequency means reduced compliance expectations. When inspections do occur, they may be more focused and may cover more ground per inspection day due to scheduling constraints. Ensure that your quality manual, procedures, and internal audit program are fully aligned with QMSR requirements and that all personnel are trained on the updated framework.

4. Build contingency timelines into your regulatory planning.

If your company's financial planning or product launch timeline assumes that a 510(k) will clear in exactly 90 days or that a PMA will be approved within the statutory window, build in additional buffer. The formal timelines have not changed, but the effective timelines -- the time from submission to clearance when accounting for pre-submission delays, slower correspondence turnaround, and the possibility of less-informative review feedback -- may be longer than historical norms.

5. Engage trade associations and collective advocacy efforts.

Industry groups including AdvaMed, MDMA, and BIO are actively engaging with HHS and congressional leadership on FDA staffing and leadership stability. Companies should ensure their concerns are represented through these channels. Individual company advocacy is less effective than coordinated industry efforts in this context.

6. Document all FDA interactions thoroughly.

In an environment where reviewer continuity is not guaranteed -- the person you speak with in a pre-submission meeting may not be the same person who reviews your submission -- detailed documentation of all FDA interactions becomes even more important. Maintain complete records of meeting minutes, correspondence, feedback received, and any verbal commitments or agreements. This documentation can be critical if questions arise during the formal review about what was discussed or agreed upon during earlier interactions.

7. Consider whether a pre-submission meeting is necessary for your situation.

Pre-submission meetings are valuable, but they are also resource-intensive for both sponsors and FDA. In a capacity-constrained environment, companies should evaluate whether a pre-submission meeting is genuinely needed or whether the same guidance can be obtained from published FDA guidance documents, precedent submissions, or experienced regulatory consultants. Reserving pre-submission requests for situations where there is genuine regulatory uncertainty or novel technology helps preserve the resource for those who need it most.

Looking Ahead

The FDA's current situation is not permanent, but neither is it likely to resolve quickly. The appointment of a new commissioner requires a nomination and Senate confirmation process that typically takes months. Even after a new commissioner is confirmed, rebuilding the agency's workforce, restoring institutional knowledge, and re-establishing operational stability will take considerably longer.

Several scenarios are possible:

Optimistic scenario: A qualified, confirmed commissioner is appointed within three to four months. The rehiring effort succeeds in restoring critical review capacity. MDUFA V metrics continue to be met, and the informal degradation in pre-submission quality and reviewer responsiveness gradually reverses. Device review returns to a functional baseline by late 2026 or early 2027.

Intermediate scenario: The confirmation process extends into late 2026 or early 2027. Acting leadership makes incremental improvements but lacks the authority and mandate to make structural changes. Rehiring proceeds slowly. Review capacity improves but does not return to pre-2025 levels. Device sponsors continue to experience elevated uncertainty and extended effective review timelines.

Pessimistic scenario: Political dynamics prevent the confirmation of a new commissioner. Acting leadership rotates. Rehiring targets are not met. The agency enters 2027 with persistent capacity gaps, and MDUFA V performance begins to deteriorate on paper as well as in practice. Device approval numbers decline, review timelines extend, and the US regulatory environment becomes less predictable relative to the EU and other major markets.

None of these scenarios involves a fundamental breakdown of the device review system. The FDA's career staff, however depleted, remains professional and committed to the agency's mission. But the range of possible outcomes is wide, and the difference between the optimistic and pessimistic scenarios is meaningful for companies making investment and strategic decisions today.

Conclusion

Dr. Marty Makary's resignation as FDA Commissioner on May 12, 2026, was not the cause of the agency's current difficulties. It was a symptom of a broader pattern of political interference, workforce destruction, and institutional instability that has been building since early 2025. The cascading leadership departures at CDER, CBER, and elsewhere in the days following Makary's exit confirm that the agency is in the midst of an unprecedented leadership vacuum.

For medical device manufacturers, the practical implications are clear: the formal regulatory requirements have not changed, but the operational environment in which those requirements are administered has degraded. Pre-submission meetings are harder to schedule. Informal feedback is less available. Reviewer expertise has been diluted by workforce losses. And the uncertainty about when -- or whether -- stable leadership will be restored makes long-term regulatory planning more difficult.

Companies that take a proactive approach -- investing in submission quality, pursuing parallel regulatory strategies, maintaining QMS readiness, and building contingency into their timelines -- will be better positioned to navigate this period than those that assume the FDA's published metrics tell the full story.

The FDA will recover. It has survived periods of political turbulence and leadership instability before, and its career workforce remains dedicated to the agency's public health mission. But recovery will take time, and the companies that plan for an extended period of operational strain will be the ones that emerge from it in the strongest competitive position.

We will continue to monitor this situation and provide updates as new information becomes available.