FDA Administration’s Center for Devices and Radiological Health (CDRH) enforces a regulatory system for medical devices based on risk, dividing them in different three classes.
FDA Class I Medical Devices
If your product falls under FDA Class I category, your device most likely does not need to obtain FDA approval or clearance to market. However, your company must perform the FDA establishment registration.
FDA Class II Medical Devices
If your medical device is a Class II device, your company will most likely need to perform a FDA 510(k) submission in order to satisfy FDA Medical Device Registration requirements for clearance to market.
FDA Class III Medical Devices
If your medical device falls under the Class III category, your company will most likely need to perform a FDA Premarket Approval (PMA) application, which includes clinical data requirements and is the most complex FDA Medical Device Registration process.
Many medical companies must also meet quality system requirements laid out in 21 CFR Part 820 in order to commercialize their products in the US.
ISOplan USA can assist your company in evaluating FDA medical device regulations as they apply to your device or IVD.