In this foundational episode, we explore how medical devices are defined and classified by the FDA—a critical first step in navigating the regulatory landscape. Starting with the legal distinction between devices and drugs, we unpack the FDA’s risk-based classification system that categorizes devices into Class I, II, or III based on their potential harm to patients. The discussion delves into how classification affects everything from pre-market submission pathways (like 510(k), De Novo, and PMA) to clinical testing, timelines, and budget planning. Through real-world examples—ranging from dental x-ray holders to implantable prostheses—the episode illustrates the diversity within each risk class and the strategic implications of classification decisions.

Listeners also receive a detailed tour through the regulatory ecosystem that supports device safety and effectiveness across a product’s lifecycle. This includes deep dives into Quality System Regulations (21 CFR Part 820), investigational device exemptions (21 CFR Part 812), and risk management standards like ISO 14971 and ISO 14155. The conversation also explores the nuances of U.S. and EU regulatory models, contrasting FDA’s centralized review with Europe’s decentralized notified body system under MDR 2017/745. With thoughtful analogies and accessible language, the episode demystifies regulatory jargon and frames device compliance as a dynamic partnership between innovation and patient safety. This is a must-listen primer for anyone transitioning from pharma to the medical device world.