Featured Medical Devices Articles
Explore the crucial distinctions between a Class I medical device, Class II, and Class III while understanding their characteristics and regulatory nuances.
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Discover the essentials of FDA medical device regulations in this guide on Premarket Approval (PMA) with Registrar Corp's expert guidance.
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Latest Medical Devices Compliance Articles
Do food, medical devices, drugs, and cosmetics need FDA approval? Read our guide on how to get FDA approval for your regulated product.
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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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Learn FDA requirements for radiation-emitting products, including reports, accession numbers, Form 2877, import rules, and performance standards.
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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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