Patient Guard

FDA Pre-Submissions

What is a Pre-Submission?

The US Food and Drug Administration’s Pre-Submission Program (Pre-Sub, formerly known as the Pre-IDE Program) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA experts. A Pre-Sub is commonly referred to as a Q-Sub, as the submission to the FDA is assigned a ‘Q’ identification number. Patient Guards’ experienced US consulting team has extensive expertise with the FDA Q-Sub process. We can guide you through this critical step toward FDA clearance.

How the FDA pre-sub process can help you achieve US market clearance for your device

The FDA Pre-Sub consulting service is a vital resource for sponsors and manufacturers, offering invaluable insights into diverse medical device- or IVD-related applications. These encompass key aspects like Investigational Device Exemptions (IDE) required for high-risk clinical investigations, precise premarket notification (510(k)) submissions, and the intricate development of clinical or non-clinical study protocols.

During the FDA Pre-Sub process, several essential topics are explored in depth. These include specific preclinical performance testing requirements crucial for bolstering clearance or approval applications. Moreover, the consultation assesses the most suitable regulatory pathway for innovative devices, such as the 510(k) route or a de novo application. Additionally, the Pre-Sub program assists in formally designating device clinical studies as either “significant risk” (SR) or “non-significant risk” (NSR).

This proactive engagement with the FDA Pre-Sub program is particularly advantageous for devices incorporating novel technologies or those with indications classifying them as pioneering “first of a kind” devices. Through this initiative, sponsors and manufacturers gain valuable feedback, ensuring their applications are well-informed and strategically positioned for success.

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How and when to start the FDA Q-Submission process

To begin a Pre-Sub meeting, formally submit a request with a comprehensive Q-Sub package. Include a cover letter summarizing your device’s use, its workings, and technological details. Clarify testing plans and pose specific questions requiring FDA guidance.

Submit this Pre-Sub request before 510(k) or premarket application reviews. It should precede clinical studies too. Although ‘Q-Sub’ meetings exist for varied purposes, Pre-Sub meetings are key. They offer vital FDA engagement during pivotal regulatory stages.

How Can Patient Guard Help?

Patient Guard, a leading medical device consultancy, offers invaluable assistance to medical device manufacturers seeking FDA pre-submission support. With our team of experienced regulatory experts, we specialize in navigating the complex terrain of FDA regulations, ensuring your product meets the stringent requirements for approval. We provide comprehensive guidance throughout the entire pre-submission process, helping you prepare a thorough and compliant submission package. By leveraging our deep understanding of the FDA’s expectations, we optimize your submission for success, increasing the likelihood of a swift and positive response. Our tailored approach addresses specific needs, streamlining the entire process and minimizing potential hurdles. Partnering with Patient Guard not only saves you time and resources but also enhances your confidence in achieving FDA approval for your medical device. Trust us to deliver expert guidance and unparalleled support, guiding your product toward regulatory compliance and market success.

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