Richard J. Kowalski
Senior FDA Regulatory & IVD Consultant | 30+ Years Experience | 510(k), De Novo, EUA Expert | Inventor of...
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, reviewer expectations, and risk mitigation, particularly for devices lacking clear predicates, including biodosimetry IVDs. Offers strategic guidance to diagnostic sponsors, federal agencies, and academic partners.
About
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, reviewer expectations, and risk mitigation, particularly for devices lacking clear predicates, including biodosimetry IVDs. Offers strategic guidance to diagnostic sponsors, federal agencies, and academic partners.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 31
- **Regions served:** US
- **Client types:** startup, sme, academic
- **Location:** United States (Virginia)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Richard J. Kowalski's unique value lies in his dual expertise as both an inventor of an FDA-cleared IVD assay and a seasoned regulatory strategist with over three decades of experience. This rare combination allows him to offer unparalleled insights into the practicalities of product development alongside the rigorous demands of FDA approval, particularly for first-of-kind diagnostics.
- **Ideal projects:** Richard is an ideal consultant for medtech companies, particularly startups and SMEs, focused on developing innovative In Vitro Diagnostic (IVD) tests, especially in the fields of hematology and pathology. He excels with projects involving complex or novel diagnostics that may not have clear predicates, requiring strategic navigation of FDA 510(k), De Novo, or EUA pathways. Companies seeking to establish robust regulatory strategies, frame compelling evidence for submissions, or manage challenging FDA interactions will find his expertise exceptionally valuable. Engaging Richard early in the development cycle for scientifically complex IVD projects, especially those funded by federal agencies, can significantly de-risk the path to market clearance.
- **Confidence score:** 95/100
- **Last analyzed:** Mon Jan 05 2026 15:37:25 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, clinical-trials
- **Specialties:** ivd, hematology, pathology
- **Device panels:** ivd
- **Regulatory pathways:** 510k, de_novo, pma, hde, post_market
- **Type:** independent
- **Years of experience:** 31
- **Regions served:** US
- **Client types:** startup, sme, academic
- **Location:** United States (Virginia)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Richard J. Kowalski's unique value lies in his dual expertise as both an inventor of an FDA-cleared IVD assay and a seasoned regulatory strategist with over three decades of experience. This rare combination allows him to offer unparalleled insights into the practicalities of product development alongside the rigorous demands of FDA approval, particularly for first-of-kind diagnostics.
- **Ideal projects:** Richard is an ideal consultant for medtech companies, particularly startups and SMEs, focused on developing innovative In Vitro Diagnostic (IVD) tests, especially in the fields of hematology and pathology. He excels with projects involving complex or novel diagnostics that may not have clear predicates, requiring strategic navigation of FDA 510(k), De Novo, or EUA pathways. Companies seeking to establish robust regulatory strategies, frame compelling evidence for submissions, or manage challenging FDA interactions will find his expertise exceptionally valuable. Engaging Richard early in the development cycle for scientifically complex IVD projects, especially those funded by federal agencies, can significantly de-risk the path to market clearance.
- **Confidence score:** 95/100
- **Last analyzed:** Mon Jan 05 2026 15:37:25 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, clinical-trials
- **Specialties:** ivd, hematology, pathology
- **Device panels:** ivd
- **Regulatory pathways:** 510k, de_novo, pma, hde, post_market
Key Highlights
- 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 marke
- Richard J. Kowalski's unique value lies in his dual expertise as both an inventor of an FDA-cleared IVD assay and a seasoned regulatory strategist with over three decades of experience. This rare combination allows him to offer unparalleled insights into the practicalities of product development alongside the rigorous demands of FDA approval, particularly for first-of-kind diagnostics.
Certifications & Trust Signals
- 31 years experience
Buyer Snapshot
Best for
- Richard is an ideal consultant for medtech companies, particularly startups and SMEs, focused on developing innovative In Vitro Diagnostic (IVD) tests, especially in the fields of hematology and pathology. He excels with projects involving complex or novel diagnostics that may not have clear predicates, requiring strategic navigation of FDA 510(k), De Novo, or EUA pathways. Companies seeking to e
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), De Novo, PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
31
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd
Technology Types:
ivd_test
Accepting New Clients:
No
