So you have a medical device and want to start selling it to help human kind… oh, and maybe turn a profit! But before you can legally market in the US, you’ll likely need to navigate the FDA submission process.

FDA determines the classification of medical devices in the US based on the level or risk they pose to patient or end user. Class I devices are thought to have the lowest level of risk and are often exempt from any premarket submission. Logically, regulatory control increases from Class I to Class III; Class III devices are often life-supporting or life-sustaining and thus carry the greatest risk. These high-risk devices and other technologically innovating devices often will require clinical studies and Premarket Approval. The majority of medical devices, however, fall within Class II and will likely require a Premarket Notification. Some of the submissions you might hear about as you navigate the regulatory landscape are:

510(k): A Premarket Notification (510(k)) is required for many moderate to high risk devices so you can be “cleared” to commercially distribute your device. A 510(k) should demonstrate that your device is substantially equivalent (SE) to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a predicate device that has been determined by FDA to be SE.

PMA: A Premarket Approval (PMA) is for products that are considered high risk and that pose a significant risk of illness or injury. The PMA process is more complex and often includes the submission of clinical data to support the claims specific to the device and its indications for use.

RFD: A request for Designation is a submission for combination products (products comprised of two or more regulated components, i.e. drug, device, biologic) where you can obtain a determination of the product’s primary mode of action. The Office of Combination Products will assign the lead center for the product’s premarket review and regulation.

IDE: An investigational device exemption (IDE) is a submission that FDA must approve to allow a device to be “investigated” or used in a clinical study. These studies are often initiated to collect safety and effectiveness data to support a PMA, or less common, a 510(k) submission.

De novo: A de novo submission is for a novel device or technology that does not have a good predicate to demonstrate substantial equivalence (via the 510(k) process) and does not possess a high enough risk profile to warrant a PMA. FDA will grant your de novo application if it believes you have adequately mitigated the potential risks.

Pre-Sub/Q-sub: A Pre-Submission is a formal written request for feedback from FDA, often prior to a formal premarket submission or IDE. Feedback (in the form of written response or meeting) often includes answers to your company’s specific regulatory questions and can be helpful in guiding product development and/or application preparation.

RA infographic

Overview of Device Regulation

How to Market Your Device

  • Dr. Allison Komiyama, Ph.D., Director of Regulatory Affairs at Neozene

    Allison is responsible for developing regulatory strategies, authoring submissions, and helping get client technologies to market. Allison, a former FDA reviewer, received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. She has expertise in regulatory submissions, quality systems, and biocompatibility evaluation.

    To discuss your particular issues and to see if Neozene can provide the assistance you need to meet your goals, email or call Neozene at 510-746-8693. And if you’re preparing for, or expect an FDA inspection in the coming months, ask about our complimentary CAPA Process Check Up.