Our expert consulting team will help you figure out how FDA would classify your medical device! Call us today at (978) 358-7307, or just click here:
Determining your medical device or product's FDA classification is a critical first step in establishing its regulatory pathway to market. The classification not only determines the type of submission required (e.g., 510(k), PMA, De Novo) but also outlines the testing, documentation, and review processes necessary for approval.
Our team of experienced consultants at RQMIS will guide you through every stage of the classification process, including the preparation and submission of a Request for Designation (RFD) to the FDA when the classification is unclear.
At RQMIS, our expertise ensures your product is accurately classified, minimizing delays and regulatory hurdles while paving a clear and efficient pathway to market approval. Let us guide you through the complex FDA classification process with clarity and confidence.
Our expert consulting team will help you figure out how FDA would classify your medical device! Call us today at (978) 358-7307, or just click here: