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 link below:
Determining the FDA classification of your medical device or product is a crucial first step in defining its regulatory pathway to market. The classification not only dictates the type of regulatory submission required—such as a 510(k) premarket notification, Premarket Approval (PMA), or De Novo classification request—but also establishes the necessary testing, documentation, and review processes for obtaining FDA clearance or approval.
At RQMIS, our team of seasoned regulatory consultants provides comprehensive guidance throughout the classification process. We conduct in-depth regulatory assessments, analyze predicate devices, and help you determine the most efficient and compliant pathway for your product. If your device’s classification is uncertain or falls into a gray area, we assist in preparing and submitting a Request for Designation (RFD) to the FDA, ensuring a well-supported argument for your product’s appropriate classification.
By leveraging our expertise, you can navigate regulatory complexities with confidence, avoid unnecessary delays, and position your medical device for successful market entry.
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 link below: