RMRAS Annual FDA Update 2026

Polaris Biomedical sponsored this year's Rocky Mountain Regulatory Affairs Society (RMRAS) Annual FDA Update meeting, and I had the pleasure of spending the evening with some of Colorado's top manufacturers and regulatory professionals. Here is my breakdown of what went down, the big structural shifts at the agency, and what this all means for medical device teams on the ground.

A Brand New Agency Map: The Shift to OII

Mark Harris kicked off the presentations by walking us through the evolution of the agency’s field structure. If you’ve been in the industry for a while, you probably remember the days of geographic district offices handling every commodity under the sun, from drugs and devices to food and biologics.  

That setup is officially a relic of the past. Following earlier program alignments, the 2024/2025 restructuring moved all field compliance operations directly into the Centers (such as CDRH and the Human Foods Program).  

The former Office of Regulatory Affairs (ORA) is now the Office of Inspections and Investigations (OII), led by Associate Commissioner Dr. Elizabeth Miller. The critical takeaway here is that OII represents the investigative and inspectional arm of the FDA, while formal compliance case development now flows straight through the Centers. If you want compliance-level enforcement data, that conversation now lives with CDRH.

Then vs. Now: What the New Citation Data Shows

Matthew Vernon, a veteran medical device investigator from the Denver office, took the stage to show what citations look like in the real world following the QMSR transition on Groundhog Day (with a still frame from the 1993 film).

Under the old Quality System Regulation (FY25 data), Form 483 citations were heavily skewed toward two usual suspects: CAPA and complaint handling, with CAPA citations alone making up around 41% of the total.  

Fast forward through the first six months under QMSR, and the landscape looks fundamentally different:

• Because investigators are no longer handcuffed to the rigid, stepwise QSIT manual, the spread of citations across quality system areas has flattened out.  

• Two brand new citations have surged into the top 10. Clause 7.1 (risk management throughout product realization) at #1, and Clause 4.1.2 (a risk-based approach across the entire QMS) at #8. Together, risk-related citations accounted for roughly 40% of the post-transition data Matt analyzed.  

• While it’s early days and steady state hasn't been reached yet, one thing is clear: if you remove the new risk citations, the remaining top issues still revolve around CAPA, complaints, purchasing, and process validation. 

Inside Compliance Program 7382.850

Brian Lowe joined virtually from the Office of Medical Device and Radiological Health Inspectorate to dive into the nuts and bolts of the new inspection program.  

Much to the room's enjoyment, Brian noted, the FDA threw a retirement party for 21 CFR 820 and the QSIT manual, complete with poems, tributes, and a Kudoboard, marking a symbolic end to a nearly 30-year era. In its place is Compliance Program 7382.850, titled Inspection of Medical Device Manufacturers.  

A few practical highlights Brian shared:

• Patient and user safety sits at the absolute center of every inspection. Investigators use your risk management files as their compass to traverse six core QMS areas and four other applicable FDA requirements (OPARs).  

• Routine surveillance, for-cause, and post-market audits fall under Model 1, where investigators evaluate at least one element across every QMS area. Model 2 is reserved for baseline surveillance (first-time facility visits) and PMA pre-approvals, requiring investigators to evaluate a much broader list of mandatory elements.  

• Failing to establish, implement, or maintain a risk management process for product realization (Clause 7.1) is explicitly listed as a condition that can trigger an Official Action Indicated (OAI) classification. 

Q&A

The open Q&A offered some of the most practical advice of the night:

• What Does a Clause 7.1 Deficiency Looks Like?: Matt Vernon gave concrete examples of what lands companies in hot water, such as seeing severe field failures or MDRs in complaint logs that are entirely missing from the FMEA, or rating patient death as a severity of "1". He stressed that risk management is living; FDA expects companies to quantitatively update their FMEAs with real-world field data rather than leaving pre-market estimates untouched.  

• How is AI used at the Agency?: While FDA is using an internal tool called ELSA to help reviewers sift through consolidated agency data and research unfamiliar devices, Brian clarified that AI is not being fed manufacturer quality records to generate inspection findings.  

• What are current EIR Timelines?: Investigators aim to submit Establishment Inspection Reports (EIRs) to supervisors within 30 days for NAI/VAI inspections, meaning facilities should generally expect their final report within roughly 60 days.  

• How does Supplier Controls fall under the new QMSR?: Under Clause 7.4, FDA expects risk management on both sides of the supply chain, auditing or evaluating suppliers, based on component criticality, backed up by appropriate incoming acceptance controls.