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Why avoiding Q-subs (presubmissions) to FDA is a terrible idea

In the realm of medical device development, ensuring the safety, effectiveness, and regulatory compliance of products is paramount. The United States Food and Drug Administration (FDA) serves as the gatekeeper, evaluating and approving medical devices before they reach the market. One crucial step in this process is the presubmission, which allows manufacturers to seek valuable feedback and guidance from the FDA. However, there is a concerning trend among some companies who opt to bypass this essential step in an attempt to expedite their product development. In this blog, we will delve into why avoiding FDA presubmissions for medical devices is not only ill-advised but also poses significant risks to patients and businesses alike.

Patient Safety as the Foremost Priority

Medical devices directly impact the lives of patients. Without engaging in FDA presubmissions, manufacturers risk overlooking crucial safety considerations and potential risks associated with their devices. Patient safety should always be the primary concern in the development and commercialization of medical devices. By bypassing presubmissions, companies increase the likelihood of introducing devices with unaddressed safety concerns, potentially endangering patients’ well-being and undermining public trust in the medical device industry.

Ensuring Regulatory Compliance

Adhering to FDA regulations is a fundamental requirement for medical device manufacturers. Presubmissions provide a crucial opportunity for companies to seek regulatory guidance and clarification, ensuring that their devices meet the necessary standards for market approval. Skipping this step significantly heightens the risk of non-compliance, which can result in delays, costly remediation efforts, and even the rejection of a product altogether. By actively participating in presubmissions, manufacturers can address regulatory concerns early on, thereby increasing their chances of successful product development and market entry.

Accelerating Product Development

Presubmissions foster a collaborative environment between manufacturers and regulatory experts. Seeking early feedback from the FDA allows companies to identify potential roadblocks, refine their development plans, and streamline the path to market approval. Engaging in presubmissions can help accelerate product development by addressing potential issues upfront, optimizing designs, and making informed decisions based on expert insights. By avoiding this critical step, companies risk encountering unforeseen obstacles, delays, and costly iterations later in the development process.

Building Market Confidence

Successfully navigating the FDA regulatory pathway enhances market confidence and increases the likelihood of product adoption. By actively participating in presubmissions, manufacturers demonstrate their commitment to quality, safety, and regulatory compliance. This engagement instills trust among healthcare providers, patients, and investors, who rely on the FDA’s rigorous evaluation process as an assurance of a device’s reliability and efficacy. Companies that choose to forgo presubmissions may face skepticism from stakeholders, impeding market acceptance and hindering potential reimbursement efforts.


The decision to avoid FDA presubmissions for medical devices has far-reaching consequences that extend beyond short-term expediency. By recognizing the importance of this topic, we understand that patient safety, regulatory compliance, and long-term business success are at stake. Engaging in presubmissions allows manufacturers to leverage valuable regulatory guidance, identify and mitigate risks, accelerate product development, and build market confidence. Prioritizing these aspects should be the cornerstone of any responsible and successful medical device development endeavor.