Medical Device Prototype Development

Medical devices in the United States are classified according to their perceived risk. The Food and Drug Administration (FDA) uses a 3-tier system to classify progressively higher risk devices (identified from low to high risk as Class I, II or III devices). As expected, the process to create novel medical prototypes benefits greatly from the understanding of the broader regulatory structure surrounding the health industry. When it goes on the market with a new device, it will be classified as Class I, II or III, so let's take a closer look at what this all means.

About medical device classifications:

• Class I medical devices (subject to general controls with and without exemptions): the lowest risk classification that a medical device prototyping can be labeled by the FDA is class I. Class I devices are only subject to "general controls ". What are general controls? These are the means by which the FDA can regulate medical devices, and cover topics such as device registration, wrong marks, prohibited devices, good manufacturing practices and more. General controls are a mechanism through which the FDA exercises control over the manufacture and marketing of medical devices.

An example of a class I device could include medical wrap or handheld medical instruments:

• Class II medical devices (subject to general controls and special controls with and without exemptions): Class II medical devices are those devices that present a moderate risk to the user and for which "general controls" are not sufficient for Ensure safety and effectiveness. Class II devices are subject to both "General Controls" and "Special Controls." Typically, Class II devices require FDA pre-marketing approval (PMA) or approval through the 510 (k) process before a device can be legally marketed. Determining what process (none at all, 510 (k) or PMA) is required is the most important determining factor for the overall development timeline and total investment in the project.

An example of a class II device could include acupuncture needles or an electric wheelchair:

 

• Class III medical devices (subject to general controls and pre-marketing approval): Class III medical devices are those with the highest associated risk. They include things like pacemakers, coronary stents and heart valves, all devices that sustain / sustain life, of substantial importance to prevent the degradation of human health, or that present a significant risk to the user. Typically, Class III devices require FDA pre-marketing approval (PMA) before they can be legally marketed. They are also subject to "General Controls." Obtaining PMA approval is a lengthy process that requires clinical data demonstrating the safe and effective use of the device in your target population.

An example of a class III device could include a pacemaker.

According to the FDA, to determine the classification of your device, you can "go directly to the classification database and look for a part of the device name or, if you know the device panel (medical specialty) to which your device belongs, go directly to the list of that panel and identify your device and the corresponding regulations ".