513(g) Request for Classification

Streamlined Device Classification Support

Streamline your medical device development with ADBC CRO’s 513(g) Request for Classification services. Our expert team provides the best guidance to ensure your device is properly classified, helping you navigate the regulatory process efficiently and accurately.

The correct regulatory pathway for a medical device can only be determined in the development and marketing of a product. A 513(g) Request for Classification is the FDA’s official determination of how a product will be classified and regulated. With the help of ADBC CRO, we can ensure your submission is precise and clear so that it meets all requirements.

Why Choose ADBC CRO for 513(g) Support?

Navigating the FDA’s regulatory framework can be challenging, particularly for devices with innovative features or uncertain classifications. ADBC CRO’s regulatory experts bring extensive experience and in-depth knowledge of FDA processes to provide you with:

  • Clarity:
    Comprehensive support to avoid delays caused by incomplete or unclear submissions.
  • Confidence
    Expert advice on how to align your regulatory strategy with FDA expectations.
  • Efficiency
    Proactive management that makes the classification process more streamlined.

Our Services Include

Device Evaluation and Classification Analysis We provide an in-depth analysis of your device's features, intended use, and regulatory precedents for its current or potential classification and requirements.
Preparation of 513(g) Request Documents Our team will draft, compile, and organize all necessary documents, such as a detailed description of the device, intended use statement, and other supporting materials.
FDA Communication Facilitation We help get your questions and requests in their best shape, structured and aligned according to the regulatory standards across the FDA.
Regulatory Pathway Recommendations Accordingly, after receiving the response, we guide you on any of the 510(k) pathways, PMA pathway, or De Novo pathway.

Benefits of a Partnership with ADB CCRO

  • Expert Insights
    Work with seasoned regulatory professionals knowledgeable about the nuances of FDA Classification Processes.
  • Time Efficiency
    Save your precious time with our diligent approach and streamlined processes.
  • Tailored Support
    Support is designed to be bespoke to the unique features of your device and regulatory needs.
  • Proactive Planning
    Plan ahead to find and eliminate potential challenges in advance.

Contact us for 513(g) classification services and FDA navigation!

Contact Now

Global Impact

Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.

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