The Chambers Practice Guide: Healthcare: Medical Devices 2026 (USA) provides a overview of the key legal and FDA regulatory framework governing medical devices in the United States, addressing the full product life cycle from design, development, and pre-market authorization through commercialization including manufacturing, advertising and promotion, post-market surveillance, and enforcement. It serves as a valuable resource for in-house counsel and compliance professionals and explores key developments affecting the device industry, including FDA oversight of AI-enabled technologies, quality system regulation harmonization, and legislative developments.

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