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.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
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
Supports Estar:
Yes
Provides Submission Project Management:
Yes
