Classification of Medical Devices in the US

This whitepaper provides a comprehensive understanding medical device classification system in the United States of America (US), aiming to assist medical device manufacturers, startups, and stakeholders in navigating the regulatory pathways under the oversight of the US Food and Drug Administration (FDA). Understanding the classification process is crucial as it determines the level of regulatory scrutiny, market approval pathways, and post-market surveillance requirements. This document also explores various types of medical products and highlights key steps for determining and confirming a product’s classification in the US market