LET'S TALK - SIMPLE REFORM

Beyond the Labels: What Really Determines Inspection Quality in Medical Products

FDA is about to reverse one of the central features of its 2017 Program Alignment. Beginning in October 2026, under the internal effort known as “Simple Reform,” specialized field investigators who handle medical products and clinical research will again operate as generalists across multiple industries. Some describe this as a necessary return to flexibility. Others warn it will erode technical depth. Both descriptions miss the more complicated reality I lived inside the Agency and still see from the outside.

I spent years as an FDA investigator, supervisor, and Director of Investigations before moving into consulting. What I learned, and what the public record largely confirms, is that the formal label on the organizational chart has always mattered less than the actual skill of the investigator and the judgment of the person assigning the work.

How the “Generalist” Model Actually Worked

Before May 2017 the Office of Regulatory Affairs was organized by geography. Every investigator started with basic training in the foods program. Those of us who came in with prior experience—mine was in drug and device work under the Texas state contract—moved into specialized training in those commodities. Over time most investigators developed real strength in one or two primary areas while still being able to handle more routine assignments in others.

The word “generalist” on paper never meant that people were interchangeable. As a supervisor and later as Director of Investigations, I knew which of my investigators could handle a complex sterile drug inspection, which ones were strongest on design controls, and which ones were still building depth. When the right expertise was not available locally, we borrowed seasoned investigators from other districts. We did not simply send whoever was free. That practical matching of skill to complexity is what kept the system functional.

I have heard the same description from other long-tenured field managers. The public record contains no systematic evidence that the pre-2017 geographic structure produced inferior medical-product inspections simply because it was not organized by commodity.

Program Alignment and the Missing Scorecard

In 2017 FDA moved to commodity-based cadres. The stated goals made sense: put deeper technical expertise against more complex products, improve consistency, and tighten the link between the field and the Centers. The medical device action plan even contemplated sub-specialties.

Nearly a decade later, however, there is still no formal public assessment of whether Program Alignment achieved those goals. No FDA evaluation, no GAO report, and no independent study has isolated the effect of specialization on Form 483 quality, classification rates, consistency of observations, or public-health outcomes for medical products. Inspection volumes and certain citation rates moved, but so did COVID disruptions, investigator vacancies, and enforcement priorities. We cannot honestly claim to know what the structural change delivered.

GAO has written repeatedly about capacity problems, foreign inspection shortfalls, and investigator attrition since it placed medical-product oversight on the High-Risk List in 2009. Those reports are useful. They simply do not answer the question of whether specialization improved the actual quality of the work.

We are now preparing to reverse the 2017 structure without ever having published a clear accounting of its results. That should give both the Agency and industry pause.

Combination Products Expose the Limits

Combination products remain the clearest illustration of the problem. When I was still inside FDA, and later while consulting, I never saw a dedicated investigator training curriculum for combination products. The people best equipped to inspect them were those who had already built real experience across drugs, devices, and biologics.

The governing compliance program allows either dual-program staffing or a single investigator with the right background. In the ten years I have spent reviewing combination-product inspections as a consultant, dual coverage has been the exception. Most of the time only the lead Center’s program shows up. When the drug side leads, design controls often receive only light attention—or none at all. Later, when a product fails and the root cause sits in the device constituent, a device investigator appears. That sequence can leave a manufacturer believing the earlier inspection was more thorough than it actually was.

Public data systems do not break out combination-product inspections. They do not track how often more than one investigator signs a Form 483. Recall records contain no reliable flag identifying combination products. Firms and the Agency itself are left to operate without shared, verifiable metrics on one of the most technically demanding product categories we regulate.

A Lost Element of Investigator Training

There is another practical shift that receives less attention. In earlier years, ORA maintained active partnerships with industry for investigator training. Industry experts came into DHRD classrooms to teach, demonstrate technology, and answer the kinds of practical questions that only people who run the processes every day can address. FDA also arranged training days at actual operating sites—EtO sterilization facilities and gamma irradiators, among others—so investigators could see the equipment, the controls, and the real-world constraints firsthand.

Those partnerships largely faded. In my view the primary driver was cost. Moving groups of investigators to multiple locations across the country became expensive, and once DHRD centralized training at its own facility the off-site component diminished. I do not believe the change was driven mainly by concerns about appearance of conflict; it was a resource decision.

The unintended consequence was a loss of real-world exposure. Classroom instruction and internal case studies are necessary, but they are not the same as standing on a production floor or inside a sterilizer control room with the people who operate the systems. As technology has grown more complex—particularly for combination products, advanced therapies, and sophisticated manufacturing platforms—that gap in practical exposure has become more consequential. Investigators benefit when they can see and question the actual processes they will later evaluate. Rebuilding limited, carefully structured opportunities for that kind of exposure would strengthen, not compromise, the quality of the training pipeline.

The Transparency Problem Is Consistent

These gaps are not new. Across both the geographic and the commodity-based eras, several basic facts have remained difficult or impossible to see from outside:

• There are no published statistics on multi-investigator Form 483s in the medical programs.

• Combination-product inspections are not isolated as a category in the public dashboards or annual reports.

• Investigator training curricula and competency expectations for medical products and combination products stay internal.

• No official evaluation has measured the effect of the 2017 reorganization—or the coming reversal—on inspection quality.

  
  

Without those data, quality and compliance leaders cannot benchmark the thoroughness of coverage they receive, especially on the non-lead constituent of a combination product. Greater transparency would let everyone move past arguments about organizational charts and focus on what the inspections actually accomplish.

Simple Reform and the Chance to Do Better

Internal announcements indicate that medical-products and clinical-research investigators will operate as generalists under Simple Reform starting in October 2026. The July 2026 Federal Register notice speaks only of reducing redundancy and improving efficiency. It does not describe when residual specialized expertise will still be required.

Steven Silverman, who once directed the CDRH Office of Compliance, has argued that it is unrealistic to expect generalists to develop the necessary depth while moving from a drug inspection one week to a biologics site the next and a device inspection after that. The underlying concern about technical depth is legitimate and deserves attention.

More important than any single voice is the pattern. We are changing the structure again without a public scorecard from the last change. It would be far more responsible to establish clear baseline metrics and periodic public reporting for Simple Reform from the beginning. Ten years from now we should be able to say what worked and what did not, rather than simply reaching for the next organizational preference.

Investigators and Centers: Distinct and Complementary Roles

It is worth being precise about what the investigator’s job is—and what it is not.

It has never been the role of the field investigator to determine the safety or effectiveness of a regulated product. That assessment belongs to the Centers through their established review programs: evaluation of clinical and non-clinical data, chemistry-manufacturing-controls information, and related scientific review. The investigator’s responsibility is different.

In the pre-approval setting, the investigator’s task is to determine whether the data and commitments presented in the application are true, factual, and can be substantiated at the manufacturing site. The inspection is the last major step in that process. Can the firm make the product as they have described it, and can they do so in accordance with the applicable GMPs or quality system requirements?

For most 510(k) devices the dynamic is similar but shifted. Substantial equivalence is decided on the submission itself. The primary question answered through inspection is whether the firm can manufacture the device in compliance with the Quality Management System Regulation (QMSR). Design controls and other quality system elements are examined on routine inspections; the premarket notification process itself does not substitute for that evaluation.

The Form 483 is written to document conditions that may constitute adulteration or that deviate from GMP or quality system requirements. The underlying premise is straightforward: significant failures in those systems can adversely affect the safety or performance of the product. The investigator is not rendering an independent scientific judgment on safety or efficacy. The investigator is determining whether the firm is meeting the regulatory expectations that are designed to support those outcomes.

This distinction matters when we talk about investigator qualifications and training. Technological understanding is important—especially for complex manufacturing processes and combination products. But the core skill is investigative: the ability to examine systems, test assertions against evidence, recognize patterns of noncompliance, and document findings clearly and accurately. Holding an advanced degree (MD, Ph.D., Pharm.D., or similar) does not automatically make someone a stronger investigator. I have seen highly credentialed individuals struggle with the practical demands of an inspection, and I have seen investigators without those credentials perform at a very high level because they possessed strong investigative judgment and disciplined technique.

In short, the investigator’s value lies less in possessing the deepest possible knowledge of one specific drug, device, or biologic and more in the consistent, rigorous application of regulatory compliance standards to the operation in front of them. That is the skill the system must continue to develop and protect, regardless of how the organizational chart is drawn.

What Has Always Mattered Most

A few realities have remained constant in my experience and in the public record.

Investigator capability has always varied. Background, prior experience, and years in the Agency matter. When I reviewed work as a supervisor, and later when I read Form 483s as a consultant, the difference between a strong observation and a weak one was usually obvious. Strong ones were precise, supported by evidence, and correctly applied. Weak ones were unclear, thin, or simply wrong for the situation.

The responsibility of leadership to know the skill of each investigator and to match that skill to the complexity of the assignment has never disappeared, regardless of the formal structure.

Resource constraints—vacancies, attrition, heavy travel—have limited capacity for years. GAO has documented this repeatedly.

The alternative tools developed during COVID (records requests under section 704(a)(4), remote interactive evaluations, and reliance on trusted foreign regulators) have been formalized to maintain oversight flexibility and to support timely application decisions when an on-site inspection is not feasible or not the best use of limited resources. They are meant to complement traditional inspections and to help address staffing and capacity shortfalls, not to replace on-site work. These tools would presumably not be impacted by Simple Reform.

The coming shift back toward generalists will not automatically improve or degrade inspection quality. Results will still turn on whether managers accurately assess individual capability, whether the remaining cross-commodity expertise is protected and shared, and whether combination-product inspections are treated as work that genuinely requires depth rather than simply the presence of the lead Center’s program.

What Industry Should Do Now

Quality and compliance leaders should expect greater variability in investigator background starting in late 2026. Document what actually happens during inspections, especially the depth of coverage on non-lead constituents of combination products. Do not assume that the formal structure guarantees thoroughness.

Industry also has an opportunity—and, I would argue, a responsibility—to help rebuild practical training pathways. The earlier model of structured partnerships, in which industry experts taught at DHRD and hosted carefully managed training days at operating facilities, gave investigators real-world exposure that classroom instruction alone cannot provide. As technology grows more complex, that kind of exposure becomes more valuable, not less. Responsible firms and trade associations should explore ways to re-engage with FDA on limited, transparent, and ethically sound opportunities for investigators to see current manufacturing technologies and processes firsthand. Done properly, such partnerships strengthen the inspection process for everyone.

FDA would strengthen its own credibility by publishing clearer criteria for when specialized expertise is still required, by improving public data on combination-product coverage and investigator preparation, and by putting a transparent effectiveness framework around Simple Reform from the start. Without measurable benchmarks we are likely to find ourselves, a decade from now, debating the next reorganization with no better evidence than we have today.

Organizational charts are easy to change. Matching real skill to real complexity, and then measuring whether patients are better protected, is harder. That harder work remains the part that actually matters.