Countless patients, clinicians, and caregivers have relied on medical devices over the years for health needs. But bringing a medical device to market in the United States is no easy task. It involves not just building the device and testing it, but also obtaining regulatory approval from the Food and Drug Administration (FDA) prior to marketing the device. What follows is a simplified overview of the regulatory process.
Medical devices are broadly grouped into three classes based on the potential risk and intended use: Class I, II, and III. Class I is the lowest risk and includes things people may not often think of as medical devices like tongue depressors and latex gloves. 47% of all devices fall into Class I. Class II devices (43% of all devices) include infusion pumps, surgical needles, and powered wheelchairs. Class III devices carry the most risk and are the least prevalent class of all devices (10%). The FDA defines these devices as “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Examples include implantable pacemakers and replacement heart valves. Devices in each of these classes may be subject to one of several pre-submission FDA regulatory pathways. Two of the most common are 510(k) and PMA.
510(k), otherwise known as pre-market notification or PMN, is the simpler and less costly route, and it is for lower risk devices. The name comes from it being in Section 510, paragraph “k” of the Federal Food, Drug, and Cosmetics Act. All Class I, II, and III devices that do not require PMA must have a 510(k) submission, unless they are subject to exemption. Most Class I devices and some Class II devices are exempt from 510(k) requirements. 510(k) notification involves identification of a legally marketed “predicate device” that is substantially equivalent to your device. Once substantial equivalence has been shown and confirmed by the FDA, the device can be marketed in the US. The time from 510(k) submission to when you hear back from the FDA is typically 90 days or less.
PMA, short for pre-market approval, is required for all Class III medical devices (unless they were on the market prior to 1976, when the FDA started regulating medical devices). It is a substantially more involved process (time and money), in some ways similar to the clinical trials process mandated for new drugs to go to market. PMA requires demonstrating the device is safe and effective for its intended use, not just that it is substantially equivalent to an existing device. The application packet requires extensive laboratory and clinical studies. Beyond the cost of developing the device, one must also factor in the cost of FDA submission. As of the time this blog was written, the standard fee for submitting a PMA application is $322,147 ($80,537 for a small business), versus $10,953 ($2,738 for a small business).
If you are trying to determine which category your device falls under, you should start by checking out the FDA’s guidelines for determining that on their website here