About
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    Ricky C. Benjamin

    Founder & Managing Partner — The FDA Law Solution, LLC

    Ricky C. Benjamin, Founder and Managing Partner
    Overview

    A Career Dedicated to Regulatory Excellence

    Ricky C. Benjamin is the founder and managing partner of The FDA Law Solution, LLC, a boutique regulatory law firm dedicated to helping innovative companies navigate the complex legal and regulatory frameworks governing products regulated by the U.S. Food and Drug Administration and related authorities.

    With more than three decades of legal experience spanning Big Law, in-house counsel roles, and senior litigation positions, Ricky advises companies operating in highly regulated industries on how to bring products to market, manage regulatory risk, and maintain compliance throughout the product lifecycle.

    His work centers on medical devices and diagnostics, Software as a Medical Device (SaMD), and artificial intelligence/machine learning (AI/ML)-enabled health technologies, extending as well to helping clients address the legal and regulatory challenges associated with pharmaceuticals, biologics, foods, cosmetics, dietary supplements, consumer products, and compounded medications. This breadth allows him to advise clients at the intersection of law, science, technology, and product commercialization across the full range of FDA-regulated industries.

    Practice Focus

    Medical Devices, SaMD & AI/ML-Enabled Technologies

    A central focus of Ricky's practice is the fast-evolving regulatory landscape for medical devices and digital health technologies. He counsels device and software manufacturers on matters including:

    Device classification and premarket regulatory pathways (510(k), De Novo, PMA)
    Software as a Medical Device (SaMD) regulatory strategy and lifecycle planning
    Predetermined Change Control Plans (PCCPs) for AI/ML-enabled medical devices
    Clinical Decision Support (CDS) software and the regulatory line between regulated and non-regulated functions
    AI/ML model risk considerations, including algorithmic bias and performance monitoring in the regulatory context
    Software documentation, cybersecurity, and quality system requirements for connected and software-driven devices
    Post-market obligations for devices incorporating adaptive or continuously updating algorithms
    Practice Focus

    Regulatory Strategy Across the Product Lifecycle

    Ricky's practice centers on guiding companies through the regulatory issues that arise from product development through commercialization and beyond. He advises clients on:

    Regulatory strategy and product classification
    Pre-market submissions and approvals
    Product labeling and promotional review
    Advertising and marketing compliance
    FDA inspections and enforcement matters
    Product recalls and regulatory investigations
    Post-market compliance obligations

    His experience allows him to help organizations anticipate regulatory risk before it becomes a compliance issue, enabling companies to move forward with confidence as they develop and market regulated products.

    Industries

    Life Sciences and Regulated Product Industries

    Ricky regularly advises companies across a wide range of FDA-regulated sectors, including:

    Medical device, diagnostic, and digital health/SaMD
    Pharmaceutical and biotechnology companies
    Compounding pharmacies operating under Sections 503A and 503B
    Food and beverage manufacturers
    Dietary supplement and nutraceutical companies
    Cosmetic and personal care product companies
    Consumer product manufacturers

    In addition to regulatory counseling, he assists companies with clinical research compliance, product development strategies, and regulatory considerations affecting mergers, acquisitions, and investment transactions, specifically involving earnouts & contingent value rights (CVRs).

    Marketing Compliance

    Marketing, Promotion, and Regulatory Compliance

    An important part of Ricky's practice involves advising companies on how to promote and market regulated products in compliance with both FDA and Federal Trade Commission requirements. He counsels clients on issues involving:

    Product labeling and claims
    Advertising and promotional materials
    Digital marketing and website compliance
    Social media promotion
    Enforcement actions involving misleading or unsubstantiated claims

    Ricky also assists clients responding to regulatory correspondence, including FDA Warning Letters, OPDP and Untitled Letters, FTC investigations, state attorney general inquiries, and disputes involving false advertising under the Lanham Act.

    Enforcement

    Enforcement and Regulatory Investigations

    Companies often seek Ricky's counsel when regulatory issues arise that could affect product commercialization or company operations. He assists clients in responding to:

    FDA inspections
    Warning letters
    Product recalls
    Consent decrees
    Product seizure actions
    Regulatory investigations

    His approach emphasizes developing strategic responses that protect the client's business while maintaining compliance with regulatory expectations.

    Background

    A Career Built on Experience and Discipline

    Ricky's path to regulatory law reflects the work ethic and discipline that continue to define his approach to client service.

    The son of a Mississippi River longshoreman, Ricky began his career loading and unloading cargo ships before entering college. While pursuing his undergraduate education, he worked night shifts at United Parcel Service and served six years in the Army National Guard as a Fire Direction Specialist in an artillery unit.

    After graduating from Southern University and A&M College, Ricky worked as a software programmer at Eastman Kodak before entering law school at the University of Iowa College of Law.

    Over the course of his legal career, Ricky developed significant experience in product liability litigation, regulatory counseling, and compliance matters, eventually focusing his practice on FDA regulatory law and related legal frameworks affecting regulated products, with a particular and growing emphasis on medical devices and software-driven health technologies.

    Approach

    Legal Philosophy

    Ricky founded The FDA Law Solution to provide clients with strategic regulatory counsel that integrates legal insight with business strategy. His approach is defined by:

    Practical regulatory guidance
    Strong analytical thinking
    Deep understanding of product-related legal risks
    A commitment to helping clients anticipate regulatory challenges before they occur

    Clients value his ability to translate complex regulatory requirements into clear strategic advice that supports innovation while protecting business interests.

    Credentials

    Education and Admissions

    Education

    J.D., University of Iowa College of Law

    B.S., Southern University and A&M College

    Licensed In

    Colorado

    Georgia

    Wisconsin

    Admitted to Practice Before

    U.S. Supreme Court
    U.S. Court of Appeals for the Seventh Circuit
    U.S. Court of Appeals for the Tenth Circuit
    U.S. Court of Appeals for the Eleventh Circuit
    U.S. District Court – District of Colorado
    U.S. District Court – Eastern District of Wisconsin
    U.S. District Court – Middle District of Georgia
    U.S. District Court – Northern District of Georgia
    Commitment to Clients

    Ricky's practice is guided by the principles of integrity, professionalism, and dedication to client success. He is known for his strong work ethic, responsiveness, and ability to address complex regulatory challenges with clarity and precision. Through The FDA Law Solution, he seeks to provide companies operating in highly regulated industries with the strategic counsel they need to bring products to market, maintain compliance, and navigate evolving regulatory landscapes with confidence.