What is an FDA consulting retainer program?

An FDA consulting retainer provides manufacturers with ongoing access to experienced regulatory professionals who support inspection readiness, compliance strategy, and regulatory decision making.

Who typically uses an FDA consulting retainer?

FDA consulting retainers are commonly used by medical device, pharmaceutical, combination product, and IVD manufacturers that require ongoing regulatory guidance.

How does the FDA consulting retainer support inspection readiness?

The retainer program supports continuous FDA inspection readiness by reviewing quality systems, regulatory documentation, and manufacturing practices to identify potential compliance gaps.

What types of regulatory support are included?

Support may include inspection readiness strategy, quality system evaluations, compliance discussions, document review, and guidance related to FDA observations or regulatory concerns.

How do consultants work with internal quality and regulatory teams?

Consultants work closely with leadership, quality, and regulatory teams to provide regulatory insight when questions arise during inspection preparation and compliance evaluations.

Can the program support companies preparing for their first FDA inspection?

Yes. Companies preparing for their first FDA inspection often use consulting retainers to strengthen quality systems, review procedures, and prepare personnel for regulatory interactions with FDA investigators.

Is the FDA consulting program only for U.S. manufacturers?

No. The program supports both U.S. and international manufacturers that distribute products in the United States and must comply with FDA regulatory requirements and inspection expectations.

How is the consulting scope determined for each manufacturer?

The scope of consulting support depends on factors such as product type, manufacturing complexity, regulatory risk level, and the condition of the organization’s quality system.

Can the consulting team assist with mock FDA inspections?

Yes. Mock FDA inspections may be conducted as part of inspection readiness activities to help identify potential compliance gaps before a regulatory inspection occurs.

Is the consulting relationship confidential?

Yes. Regulatory discussions, document reviews, and operational information shared during consulting activities are treated as confidential.

In Vitro Diagnostics (IVD)

CIRG provides FDA Consulting for in vitro diagnostic manufacturers navigating U.S. regulatory and quality requirements. We help companies address 21 CFR Part 809, QMSR, ISO 13485, labeling, quality systems, and inspection readiness. IVD compliance can involve product-specific risks, complex documentation, and close FDA scrutiny. Our approach focuses on practical execution, strong records, and clear regulatory strategy. CIRG also helps manufacturers identify gaps before they become inspection findings or costly delays. With direct FDA inspection and compliance experience, we evaluate your systems from a regulator’s perspective and help your team prepare with greater confidence.

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FDA IVD Regulatory Requirements and 21 CFR Part 809

FDA regulates in vitro diagnostic devices as medical devices, but IVD requirements extend beyond one regulation. 21 CFR Part 809 contains important IVD-specific provisions, especially labeling requirements for reagents, instruments, systems, and related products. Manufacturers may also need to address classification, premarket submission, establishment registration, device listing, QMSR, reporting, and other applicable device requirements. Intended use plays a major role because it influences labeling, performance evidence, and regulatory pathway. CIRG provides FDA Consulting to help IVD manufacturers identify which requirements apply to their products and operations. We review regulatory status, labeling, quality systems, records, and inspection readiness as connected compliance elements. A clear regulatory framework helps manufacturers avoid gaps that can delay market access or create unnecessary FDA scrutiny.

IVD Quality Systems Under QMSR and ISO 13485

IVD manufacturers subject to FDA device quality requirements must comply with the Quality Management System Regulation under 21 CFR Part 820. QMSR became effective on February 2, 2026, and incorporates ISO 13485:2016 by reference. The framework strengthens alignment between U.S. device CGMP requirements and internationally recognized quality management principles. Risk management now plays a more explicit role throughout the quality system. However, ISO 13485 certification alone does not establish full FDA compliance. Manufacturers must also meet applicable FDA statutes and device regulations. CIRG FDA Consulting helps IVD companies evaluate QMSR implementation, documentation, management controls, and inspection readiness. We focus on whether the quality system produces reliable evidence of control across design, production, complaints, corrective actions, suppliers, and postmarket activities.

MDSAP for IVD Manufacturers

The Medical Device Single Audit Program allows a recognized Auditing Organization to conduct one regulatory audit against requirements from participating jurisdictions. IVD manufacturers that market devices internationally may benefit from this coordinated approach to quality system oversight. FDA participates in MDSAP and accepts qualifying MDSAP audit reports as a substitute for routine FDA surveillance inspections. However, participation does not remove FDA’s authority to inspect a manufacturer when circumstances warrant. CIRG FDA Consulting can help IVD manufacturers prepare for MDSAP by reviewing quality system alignment, audit readiness, documentation, and regulatory gaps. We do not act as an MDSAP Auditing Organization. Instead, our role focuses on readiness and practical preparation. Companies should understand both MDSAP expectations and FDA-specific requirements before relying on a successful international audit strategy.

IVD Labeling, Intended Use, and Regulatory Claims

VD labeling must clearly communicate what the device does, how users should operate it, and where its limitations apply. 21 CFR 809.10 sets specific labeling requirements for IVD products, including intended use, warnings, test methodology, performance information, and other required details. The intended use statement deserves particular attention because FDA evaluates the device in relation to that stated purpose. It can affect classification, performance expectations, and the appropriate premarket pathway. CIRG FDA Consulting helps manufacturers review labels, package inserts, instructions, claims, and supporting evidence for consistency. We also examine whether promotional language creates claims that extend beyond the cleared or approved intended use. Clear, accurate labeling reduces regulatory risk and helps users understand the device’s proper application, limitations, and expected performance.

Analytical and Clinical Performance Requirements

FDA evaluates IVD performance according to the device’s intended use, technology, risk, and regulatory pathway. Analytical performance commonly addresses characteristics such as accuracy, precision, analytical sensitivity, analytical specificity, and other test-specific measures. Clinical performance may also require evidence when analytical results alone do not establish the device’s clinical validity or usefulness. FDA’s expectations vary by device type, so manufacturers should not apply one validation template to every assay. CIRG provides FDA Consulting to help IVD manufacturers evaluate performance strategies, protocols, acceptance criteria, records, and supporting documentation. We focus on whether the evidence supports the intended use and regulatory claims. Strong performance planning reduces avoidable deficiencies and helps manufacturers present a clearer scientific rationale during premarket review, quality audits, and FDA inspections.

Design, Risk Management, and Validation for IVDs

IVD development requires disciplined design controls, risk management, and validation throughout the product lifecycle. Under QMSR, ISO 13485:2016 provides the quality management framework, while risk-based decisions should guide design and development activities. FDA also recognizes ISO 14971 for medical device risk management, including IVD devices. Manufacturers should connect user needs, design inputs, outputs, verification, validation, risk controls, and design changes through clear documentation. CIRG FDA Consulting helps companies evaluate whether these elements form a coherent and defensible development record. We also review validation strategies for software, instrumentation, reagents, methods, and other critical components when applicable. Effective design controls do more than satisfy documentation requirements. They demonstrate that the manufacturer understood foreseeable risks, verified requirements, and validated the finished device for its intended use.

Preparing for an FDA IVD Inspection

FDA now conducts medical device manufacturer inspections under Compliance Program CP 7382.850 rather than the former QSIT approach. IVD manufacturers should prepare to demonstrate compliance with QMSR and other applicable FDA device requirements through records, processes, and employee knowledge. Inspection preparation should include management oversight, design activities, supplier controls, complaints, CAPA, production, validation, and postmarket obligations. CIRG FDA Consulting helps IVD manufacturers test readiness before FDA arrives. We review records, trace issues across processes, challenge weak investigations, and assess how well employees can explain their responsibilities. A mock FDA inspection can expose gaps that routine internal audits may overlook. Effective readiness depends on evidence that the quality system actually works, not simply on having procedures that appear complete on paper.

FDA IVD Compliance Support

CIRG provides FDA Consulting for IVD manufacturers that need practical support across regulatory, quality, and inspection readiness activities. Engagements can include QMSR gap assessments, ISO 13485 alignment, MDSAP readiness, labeling review, design controls, risk management, CAPA, complaints, supplier controls, and mock FDA inspections. We can focus on one high-risk issue or evaluate a broader quality system. Our approach emphasizes evidence, execution, and the regulatory risks most likely to matter during FDA review or inspection. CIRG also helps management prioritize corrective actions based on significance rather than paperwork volume. Strong compliance support should improve both regulatory readiness and operational control. The objective is straightforward: identify meaningful weaknesses early, strengthen the system, and reduce the chance that preventable issues become inspection findings or costly remediation projects.

IVD Compliance Through an FDA Inspection Perspective

IVD compliance looks different when viewed through an FDA inspection perspective. Investigators can move from one record or quality event into connected processes when the evidence suggests broader risk. A complaint may lead to CAPA, design, supplier, production, validation, or reporting questions. CIRG FDA Consulting applies this inspection-focused perspective when reviewing IVD quality systems and regulatory readiness. We examine whether procedures match actual practice and whether records support management decisions. Particular attention goes to recurring problems, weak investigations, incomplete risk assessments, unsupported claims, and inconsistent documentation. Our goal is to identify issues before an investigator turns them into observations or deeper inspectional concerns. Preparing from this perspective helps management understand not only whether a requirement exists, but how FDA may test compliance during an actual inspection.