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    A Regulatory Perspective: FDA Final Guidance for Design Changes Requiring new 510(k) Submissions

    This article explores key elements of FDA's final guidance to the medical device industry for deciding when to submit a new 510(k) for medical device hardware and software design changes issued 25 October 2017. The author assesses the potential business impact and suggests what companies need to do to align with FDA's final guidance. Introduction In response to technological advancements, broadening medical knowledge and clinical use, medical device designs frequently...
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    When to Submit a 510(k) (Devices and Software): A Regulatory Perspective

    This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking. Introduction The design of a medical device often evolves over time. Design changes may be in response to changes in ...