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Listen "201 - Overview of the FDA"
Episode Synopsis
The FDA's oversight is crucial as it covers various aspects of the medical device industry, including the path to market, post-market surveillance, device recalls, and key definitions. Medical devices are categorized into Class I, II, and III, with each class subject to different levels of regulation. HTM professionals in healthcare organizations play an essential role in ensuring compliance with FDA guidelines to manage medical devices safely and efficiently, benefiting patient care outcomes.
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