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Medical Device - Product Classification

Navigating FDA Classification: Defining Your Product's Regulatory Pathway with Confidence

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.

Success Story

Successful Medical Device Product Classification

Key Questions to Determine Your Product's FDA Classification:

  1. What is the Intended Use of the Product?
    • What medical purpose does the product serve? Is it intended for diagnosis, prevention, treatment, or monitoring of a condition or disease?
  2. What are the Indications for Use?
    • What specific conditions or patient populations is the product intended for?
  3. How Does the Product Achieve its Intended Use?
    • What is the Primary Mode of Action (PMOA)? Is it mechanical, chemical, or biological?
  4. What is the Product's Risk Level?
    • What are the potential risks associated with product failure or misuse?
  5. Are There Similar Products on the Market?
    • What classification were they given by the FDA?
  6. Does the Product Include Software or Digital Components?
    • Is it considered a Software as a Medical Device (SaMD) or part of a combination product?

How RQMIS Can Help:

  • Classification Analysis: Evaluate your product’s technology, intended use, and PMOA to determine the most appropriate regulatory classification.
  • Regulatory Strategy: Develop a roadmap tailored to your classification to streamline approval timelines.
  • Request for Designation (RFD): Prepare and submit RFDs to the FDA to clarify product classification and lead review center.
  • Pre-Submission Support: Assist with FDA pre-submission meetings to align on expectations before formal submission.

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.

Learn more about our Regulatory Pathway Design here.

How will FDA classify your medical device/product?

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:

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