RK

Richard J. Kowalski — 510(k) & De Novo Consultant (IVD)

Founder & Principal, NextPhaseDx, LLC

Highly accomplished Senior FDA Regulatory & IVD Consultant with over 30 years of experience driving successful in vitro diagnostic (IVD) development through FDA 510(k), De Novo, and EUA pathways. Proven expertise in regulatory strategy, evidence framing, and FDA engagement for complex and novel diagnostics. Inventor of the FDA-cleared ImmuKnow® assay. A trusted advisor for regulatory defensibility...

Experience: 31+ years

Expertise & Specializations

Regulatory Pathways

510(k)De NovoPMAHDEPost-market

Device Specialties

IVD

Regions Served

Richard J. Kowalski provides regulatory consulting services to clients in:

United States (FDA)

Credentials & Recognition

Education & Credentials

Holds a Ph.D. in Molecular Biology from Vanderbilt University and a B.A. in Biochemistry & Molecular Biology from the University of Maryland, Baltimore County. Further enhanced by postdoctoral training at NIH/NCI and the University of Florida. This strong scientific foundation provides a critical understanding of biological systems, essential for navigating the complexities of IVD regulatory submissions and scientific validation.

Recognized as the inventor of the FDA-cleared ImmuKnow® Immune-Function Assay, a landmark achievement in diagnostic development. Has advanced BARDA- and NIAID-funded diagnostics to a mature stage of readiness for regulatory submission. Serves as a Blue Ribbon Panelist for NIAID/RNCP Strategic Plans and as an NIH/NIAID Grant Reviewer, underscoring significant contributions to the field and a respected industry standing.

Professional Experience

A seasoned professional with over 30 years of experience as a Senior FDA Regulatory & IVD Consultant. Founded and leads NextPhaseDx, LLC, providing expert advisory services for IVD development. Previously served as Chief Scientist at ASELL, LLC, overseeing national emergency preparedness diagnostics, and as Scientific & Assay Development Lead at Northrop Grumman Corp. for biodosimetry programs. Notably, invented and led the product development for the first FDA-cleared immune-function IVD assay, ImmuKnow®, demonstrating a consistent ability to drive innovative diagnostic products from concept to market.

Executive Summary

Professional Overview

Highly accomplished Senior FDA Regulatory & IVD Consultant with over 30 years of experience driving successful in vitro diagnostic (IVD) development through FDA 510(k), De Novo, and EUA pathways. Proven expertise in regulatory strategy, evidence framing, and FDA engagement for complex and novel diag...

Core Specializations

Regulatory Pathways

510(k)De NovoPMAHDEPost-market

Device Specialties

IVD

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Regions: US
  • Background: 31+ years of regulatory experience.

Cruxi view

With an exceptional 31 years of experience, Richard J. Kowalski stands out as a preeminent FDA regulatory consultant specializing in In Vitro Diagnostics (IVDs). His profound expertise spans the intricate 510(k), De Novo, and Emergency Use Authorization (EUA) pathways, making him invaluable for medtech companies navigating complex regulatory landscapes. His proven success as the inventor of the FDA-cleared ImmuKnow® assay underscores his ability to translate novel diagnostic concepts into market-ready products. Richard's deep understanding of regulatory strategy, evidence framing, and direct FDA engagement is crucial for companies developing devices, particularly those lacking clear predicates or requiring advanced scientific validation. His comprehensive services, including pathway assessment, test strategy, and deficiency support, offer a robust framework for regulatory success and risk mitigation.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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