<p style="text-align: justify"><span style="font-size: 16px">The Q-Sub Program enables medical device and in vitro diagnostic companies to meet with FDA reviewers before a formal submission to raise questions, receive non-binding feedback, and ensure alignment with regulatory expectations.</span></p><p style="text-align: justify"><span style="font-size: 16px">This is not approval. It is not a shortcut. It is a structured conversation.</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p><p style="text-align: justify"><span style="font-size: 16px"><strong>Example:</strong> Developing a novel medical device. You spent years researching, prototyping, and conducting clinical studies. You're about to submit to the FDA, but you are uncertain about your testing approach or whether your work fully meets regulatory requirements. Errors could lead to delays, additional studies, or rejection. This is precisely where the Pre-Submission Program (Q-Sub) plays its most important role.</span><span style="font-size: 21px"> </span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></p><h2 style="text-align: justify"><span style="font-size: 20px">What is the purpose of the FDA Pre-Submission Program (Q-Sub)?</span><span style="font-size: 21px"> </span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></h2><p style="text-align: justify"><span style="font-size: 16px">Submitting to the FDA without prior regulatory clarity significantly increases the risk of delays or rejection:<span style="background-color: rgb(198, 198, 198) !important"> </span></span></p><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">The Q-Sub program provides FDA feedback on your proposed bench testing, animal studies, or clinical trial design.</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="text-align: justify"><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">Obtain early feedback on study design before investing millions in clinical research. This helps evaluate whether the FDA will accept the final data package.</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">The FDA provides instructions on the appropriate regulatory pathways according to device classification, including 510(k), De Novo, and PMA.&nbsp;</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><p style="text-align: justify"><span style="font-size: 16px"><span class="NormalTextRun SCXW203465106 BCX8"></span></span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">Discuss novel or complex technologies, such as AI applications, new materials, or emerging mechanisms of action. The Q-Sub program provides a structured setting to initiate that regulatory dialogue.</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">Use the Q-Sub process to resolve any misalignments between your approach and FDA regulatory standards.</span><span style="font-size: 21px"> </span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><h2 style="text-align: justify"><span style="font-size: 20px">What is the process of the FDA Pre-Submission Program (Q-Sub)?</span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"></span></h2></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><p style="text-align: justify"><span style="font-size: 16px">The (Q-Sub) process is straightforward:<span style="background-color: rgb(198, 198, 198) !important"> </span></span></p></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ol><li style="font-size: 16px">Prepare a Q-Sub package, a written document outlining your device, your questions, and your proposed approach.</li><li style="font-size: 16px">Submit your prepared Q-Sub package to the FDA.</li><li style="font-size: 16px">The FDA confirms receipt and determines the appropriate response format, which may include written feedback or a meeting, depending on the request. (in-person, phone, or by video).</li><li><span style="font-size: 16px">Receive documented, non-binding feedback on the FDA’s current regulatory stance.</span><span style="font-size: 21px"> </span><br></li></ol></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><p style="text-align: justify"><span style="font-size: 16px">The FDA aims to respond to most pre-submissions within 70 calendar days.</span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></p></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><h2 style="text-align: justify"><span style="font-size: 20px">Who can use the FDA Pre-Submission Program (Q-Sub)?</span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></h2></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><p style="text-align: justify"><span style="font-size: 16px">The Pre-Submission Program is used by everyone from large <a href="https://www.ddregpharma.com/what-are-medical-devices">medical device</a> corporations to small startups navigating the FDA regulatory process for the first time.</span><span style="font-size: 21px"> </span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></p></div></div><div style="text-align: justify"><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><p style="text-align: justify"><span style="font-size: 16px">The Q-Sub program is available to any medical device sponsor, which includes:<span style="background-color: rgb(198, 198, 198) !important"> </span></span></p></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">Combination products are those products that combine a medical device with a drug, biologic, or another device component.</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">Medical devices seeking 510(k), De Novo, or PMA pathway.</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">In <a href="https://www.ddregpharma.com/what-is-in-vitro-diagnostic-regulation-ivdr">Vitro Diagnostics</a>(IVDs).</span><span style="font-size: 16px;background-color: rgb(198, 198, 198) !important"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative; text-align: justify"><ul><li><p style="text-align: justify"><span style="font-size: 16px">Sponsors developing AI-powered tools and software as a Medical Device (<a href="https://www.ddregpharma.com/what-is-a-software-as-a-medical-device">SaMD</a>).</span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></p></li></ul></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><h2 style="text-align: justify"><span style="font-size: 20px">DDReg Capability</span><span style="background-color: rgb(198, 198, 198) !important;font-size: 21px"> </span></h2></div><div style="-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; text-align: justify"><p style="text-align: justify"><span style="font-size: 16px">Regulatory success generally depends on decisions made long before submission. At DDReg, our <a href="https://www.ddregpharma.com/global-reach/regulatory-services-in-usa">US-FDA Regulatory Consultants</a> help teams prepare for those interactions, bringing clarity and efficiency to every FDA engagement.</span></p></div></div>

What is the FDA Pre-Submission Program (Q-Sub)? Learn how this voluntary pathway streamlines medical device approvals, reduces review timelines, and minimizes risks.