Food, Drug & Cosmetic Act, Section 510(k)
FDA 510(k) Premarket Notification (PMN)
RAQA has successfully aided with the FDA 510(k) applications for diverse medical device manufacturers worldwide. However, please note that a Premarket notification under Section 510(k) is the beginning of your medical device. Once you receive a substantially equivalent (SE) letter, you must comply with the Quality System Regulations (QSR) or the new Quality Management System Regulation (QMSR), which aligns closer to ISO 13485.
FDA 510(k) Premarket Notification (PMN) under Food, Drug & Cosmetic Act (The Act), Section 510(k)
FDA REGULATORY SUBMISSIONS
The FDA 510(k) is a clearance or premarket notification. The Food, Drug, and Cosmetic Act, Section 510(k) requires device manufacturers to submit a notice to the FDA 90 days before they intend to market a medical device. It is also called 510(k) Clearances, Substantially Equivalent Letter (or SE Letter), or Premarket Notification (PMN). It must not be confused with premarket approval (PMA) under Section 515.
Predicate Device & FDA 510(k) PMN
For new medical devices marketed after 1976, under the Medical Device Amendments to the FD&C Act of 1976, manufacturers must submit a premarket approval under Section 515. However, legally marketed devices before May 28, 1976, are known as a “predicate” or “preamendments device.” These legally marketed devices do not require 510(k) submission or a PMA under Section 515. Therefore, if your device is substantially equivalent (SE) to one of those predicate devices, you can submit a clearance request under Section 510(k).
For some low-risk devices, the FDA may reclassify them to the list of 510(k) exempted devices. The list is updated periodically, so check if your device is also 510(k) exempted.
Even though FDA 510(k) submission is required 90 days before your intent to market your device, it may take longer than 90 days to get a clearance letter from the FDA. Therefore, you may want to plan and submit early. Sometimes it takes less than 90 days, but it could take much longer. Also, there is no form or template for submitting a notification.
You don’t want to assign anyone for this critical submission part.
Many consultants out there with some training or experience can prepare a 510(k) application. However, you must be cautious about whatever you submit to the agency. Whatever you send to the agency will become the final medical device, which could differ from your device. The same reason you wouldn’t hire someone to represent you in court applies here: you must perform due diligence when assigning someone to prepare for an FDA 510(k).
Medical Devices and In-Vitro Diagnostics in an all-in-one package.
FDA 510(k) Submission, QSR, ISO 13485, and Mock FDA Inspections.
Also, you must comply with the new QMSR to be ready for an FDA inspection. Evidently, some foreign corporations make the mistake of thinking that a 510(k) is all they need to distribute or market a medical device. But it is just the beginning.
Beware so called the FDA Consultant who cuts corner with AI.
Why You Should Not Hire a Consultant Who Uses AI to Draft FDA 510(k) Submissions
Don’t Rely on AI
Moreover, AI systems may pull language or formatting from previously cleared FDA 510(k)s without fully grasping the context. This may result in a submission that does not accurately describe your medical device, its clinical utility, or its engineering justification. This is particularly dangerous if the AI underrepresents risks, misstates indications for use, or misapplies recognized standards. In contrast, a seasoned ex-FDA reviewer understands the unspoken “review logic” and current FDA trends. They can craft a narrative that preempts reviewer concerns, ensures alignment with internal FDA policies, and integrates real-world review experience. Submissions created with this level of foresight and strategic positioning are far more likely to proceed smoothly and minimize review cycles.
In short, while AI may assist in document formatting or information retrieval, it should never replace expert regulatory strategy. When it comes to FDA submissions, precision is power, and shortcuts are liability.
Why FDA 510(k) Must Accurately Represent Your Medical Device – Beyond Approval
When the FDA inspects your medical device quality system, they are not simply reviewing documentation—they are evaluating the consistency between your actual device and your regulatory submissions, particularly your 510(k). FDA investigators will compare the device being manufactured, labeled, and marketed against the FDA 510(k) submission that was cleared. If there are discrepancies—such as differences in intended use, design specifications, materials, sterilization methods, or labeling—this can trigger serious compliance issues. Such findings may result in the FDA issuing a Form 483, Warning Letter, or even enforcement actions, including recalls or import alerts.
This underscores a critical truth: an FDA 510(k) submission is not just a regulatory hurdle to obtain clearance.
It is a legal and technical declaration that defines what your product is, how it functions, and how it complies with applicable regulations. A poorly constructed or generic submission—especially one created by AI tools or unqualified consultants—risks misrepresenting your device in ways that could later compromise your quality system and legal standing. An experienced regulatory professional, ideally a former FDA reviewer, understands how to draft an FDA 510(k) that not only secures clearance but also aligns tightly with your actual device and manufacturing process. They know how to anticipate and address issues that FDA investigators look for during inspections. Ultimately, your 510(k) should be a faithful and strategic representation of your product, not a templated or AI-generated document. Choosing the right expert is not just prudent—it is essential for long-term compliance and business integrity.