Part 1 – Medical Device Design
June is our month to examine how new medical devices are approved. In this 4-part series we’ll focus on FDA regulatory pathways, although much of what we discuss can be applied in other jurisdictions. Global harmonization of device regulations is at a relatively early stage; however, frequent review of work by the International Medical Device Regulators Forum (IMDRF) will enable rapid approval in other jurisdictions.
Efficient medical device development starts with a clear statement of the products intended use including the diseases or conditions treated, target patient population, device operators or users, and functions of operation. The design process uses the intended use to guide the engineering of the device in development. This includes planning for the shape, size, and color of the device, choosing materials and technologies used to mold, build, and assemble it, and creating the packaging, labeling, and instructions for use. Together they establish a scientifically sound basis for the structure and function of the device. A clear and well documented design facilitates identification of regulatory pathway, application submission/review/approval, and postmarketing control of production processes. The design process also identifies the risks of the product and documents the device components and functions that mitigate those risks. With a reasonably clear design (including a robust intended use statement), you may identify the appropriate regulatory pathway for your device and understand the data needed to prepare your submission.
In the next post, we’ll discuss how to determine if your device meets the definition of a device and obtain feedback from the FDA on the regulatory pathway. Learn more about US medical device regulations using the CDRH Learn web page. The IMDRF web pages are a starting point for medical device regulations in other jurisdictions.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers