What is for the FDA considered a "Class I, II or III" medical device?
At Foam Creations, we are often asked this question, which is a significant one to be cleared at the beginning of the design process for any medical device.
FDA classifies these devices analyzing the risks associated with the device. Devices are categorized into one of three groups, Class I, Class II, and Class III.
Class I devices are considered to be low risk and are consequently subject to the least regulatory controls. For instance, elastic bandages are categorised as Class I device. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.
Class II devices are higher risk devices than the Class above (I) and require more exhaustive regulatory controls to offer reasonable guarantee of the device's safety and efficacy. For example, condoms are categorized as Class II devices.
Class III devices are often the utmost risk devices and are for this reason subject to the maximum level of regulatory control. Class III devices must normally be authorized by FDA before they are brought to the market. For example, replacement heart valves are classified as Class III devices.
Foam Creations, specializing in XL EXTRALIGHT® foam injected components, can help develop a strategy to develop and bring to market successful medical devices.
We offer superior quality foams that do not promote bacterial growth, are closed cell, lightweight, washable and sterilisable, latex-free, non-toxic, chemical resistant and with hardness varying from very soft to very hard, whenever comfort, lightweight, specific environmental demands and texture definition are a concern.
Give us a call to start discussing your new or ongoing project.