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    Integrating FDA Meetings into a Medical Device Regulatory Strategy

    This article focuses on the strategic use and suitability of a Q-Submission program. Introduction An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the...
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    Focus Feedback: Let us Know How We're Doing

    Here at Regulatory Focus , we like hearing from our readers. It helps us to calibrate how we write, the topics we cover, the layout of our content and the information we provide. Most of the time, this feedback is sporadic, occurring when we either impress you (thankfully often, if our inbox is any indication) or make an error (thankfully not nearly as often). But now we want to invite you, our readers, to provide us with some feedback on how we're doing here at Focus...