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GxP Lifeline

Showing items tagged as FDA 510(k)

  • 2018-bl-thumb-modernizing

    Modernizing the FDA's 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 2

    This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.

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  • 2018-bl-thumb-modernizing

    Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 1

    This blog post is the first of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. Part 1 discusses key points of the ICIJ investigation on the medical device industry, the FDA’s response, and the implications of this hot-button public debate in the near future.

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  • MasterControl Logo

    Regulatory Manager Tip: Making Your Voice Heard at the FDA

    As a life science manufacturer, how can I minimize risk and hiccups before seeking U.S. Food and Drug Administration approval for my product? Learn how to make your voice heard at the FDA in this month’s Regulatory Manager Tip.

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