Learn what FDA medical device listing means, who must list, and how it supports compliance, tracking, and market access in the U.S.

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Explore FDA medical device labeling rules under 21 CFR 801 and 820.120, including required elements, formatting, QSR controls, and submission tips.

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Understand FDA's GUDID system, UDI submission rules, and device labeler requirements for compliance with 21 CFR Part 830 and Part 801.

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Learn how Device Master Files support FDA submissions, protect trade secrets, and streamline approvals for device components and materials.

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Discover what defines an FDA Class III medical device, why PMA is required, and how to navigate the strictest regulatory path in the U.S. market.

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Explore FDA Class II medical device requirements, including 510(k), special controls, QMS, software, and postmarket compliance strategies.

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