APDC can help you with the regulatory pathway for your pediatric medical device. Understanding some of the basics early in the process can save you both time and money in terms of meeting regulatory requirements along the path to commercialization of your product. The US Food and Drug Administration (FDA)’swebsite is an excellent source of information, and they have a wide range of educational material online. APDC is happy to assist along the way.
To market a medical device in the United States, inventors must follow the Federal Food, Drug and Cosmetic (FD&C) Act. The Center for Devices and Radiological Health (CDRH) at the FDA evaluates evidence for the safety and effectiveness of all medical devices. A great resource for learning about medical device regulatory requirements is CDH Learn. From this site you can become familiar with the basics of device regulations, product codes, the device classification system (and risk categorization), and general controls required for these categories.
Medical device classifications are categorized, based on the potential risk of the device to patients, and the controls that are necessary to mitigate (or adequately control) that risk. A device that’s pretty safe, like a tongue depressor, would be Class I, and a device like a heart-lung bypass machine would be Class III, because problems with one of those could be serious. In between is Class II, for devices that are moderate risk. Before a device can be sold in the United States, it must obtain either approval or clearance from CDRH at the FDA.
High risk devices (Class III) require premarket approval, or PMA. Approval usually requires clinical trials to gather the data needed to demonstrate safety and effectiveness. To use a device in a clinical trial requires another application, for an Investigational Device Exemption, or IDE. The IDE allows the device to be used only in trials, not commercially, but it is required in order to conduct the clinical trials that are necessary to obtain the PMA.
A different path is required for Class II devices, called premarket notification, or 510(k) using a predicate device. A predicate device is a product similar to your new product with the same intended use, that is already legally marketed. You will have to demonstrate that even if there are technological differences between your device and the predicate device, the differences don’t raise different questions of safety and effectiveness. If you cannot find a predicate device that is “substantially equivalent” to your product, there is still another path, the 510(k) de novo process that can be used in some cases. The 510(k) notification pathway does not necessarily (but might in some cases) require clinical trials.
Class I devices are in many cases exempt from the premarket notification process, and do not require FDA review. However they are not exempt from general controls and they must 1) be suitable for their intended use, 2) be adequately packaged and properly labeled, 3) have establishment registrations and device listing forms on file with the FDA, and 4) be manufactured under a quality system. Some Class II devices are exempt from the 510(k) notification process as well.
Class I and Class II devices are subject to general and some special controls, which means that you as a developer must follow the Quality System Regulation, also known as Current Good Manufacturing Practices, (cGMPs or GMPs). The goal is quality assurance, making sure that the product’s design, packaging, labeling, and manufacturing meet certain standards, and that the data provided for its evaluation are sound.
While you are in the process of preparing your regulatory submission and planning any required studies, you can, in some cases, seek advice from the FDA through the pre-submission process. Once you get clearance or approval for marketing, you must register and list the device with the FDA. And you’ll need to be sure that post-market surveillance controls are in place to track adverse events among other things.
Consulting an experienced regulatory consultant is almost always preferable to seeking regulatory approval on your own. APDC can advise you on your regulatory strategy and process, but cannot do the necessary research into the needs of your specific project.
Another excellent source of information is CDRH’s National Device Curriculum. This site includes case studies and other educational material, from which much of the text on this APDC webpage is adapted.