Hello
Pablo Morales, MD, is a seasoned expert in medical device regulation, with over 16 years of experience at the FDA where he specialized in reviewing medical devices. His extensive background provides him with a unique perspective of the regulatory landscape, enabling him to guide businesses through the complexities of regulatory compliance. Now, as a consultant, Pablo is committed to helping businesses navigate the regulatory process efficiently and effectively, ensuring that their products meet the necessary standards for market entry. With his deep knowledge and dedication, clients can trust Pablo to support their regulatory needs.
My Story
I’m Pablo Morales, a physician and regulatory expert with over 16 years of experience at the U.S. Food and Drug Administration (FDA), where I led the clinical review of more than 1,000 medical device submissions—including PMAs, IDEs, 510(k)s, Early Feasibility Studies (EFS), Humanitarian Device Exemptions (HDEs), breakthrough device designations and medical device recalls.
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My clinical background includes medical training at Universidad Pontificia Bolivariana in Colombia, surgical training in vascular surgery at Guy’s and St. Thomas’ Hospital in London, UK, and a two-year research fellowship at the Cleveland Clinic focused on endovascular innovation.
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At the FDA, I served in multiple senior leadership roles, most notably as Chief Medical Officer in the Office of Clinical Evidence and Analysis within the Center for Devices and Radiological Health (CDRH). In this capacity, I provided strategic clinical oversight across a wide range of device types and regulatory pathways. I was deeply involved in the development of key FDA guidance documents, including those shaping the Agency’s approach to benefit-risk assessment, regulatory decision-making under uncertainty and the 510(k) modernization efforts.
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I also played a pivotal role in the implementation of the Early Feasibility Study (EFS) pathway and led several of the original pilot projects that helped transform early-stage device evaluation in the United States. My regulatory work has consistently focused on innovation, safety, and effectiveness with the aim to improve patient outcomes.
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Beyond device review, my expertise includes bioethical guidance and regulatory support across FDA regulated medical products, with a focus on complex ethical issues in clinical protocols and marketing applications. I advised on studies conducted under 21 CFR 50.24 (Exception from Informed Consent for Emergency Research), real-world evidence, and post-market study designs. I also co-chaired initiatives within public-private partnerships, guiding collaborative efforts to improve data quality and post-market evidence for medical devices.​ In addition, I was a member of the FDA IRB.
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Through my consulting practice, I bring this deep regulatory insight and leadership experience to support companies at every stage of the product lifecycle—from early development and clinical strategy to FDA interactions and submission preparation. My goal is to help innovators navigate complex regulatory landscapes with clarity, confidence, and purpose with the aim to improve patient outcomes.
