Premarket Approval (PMA) of Medical Devices – Understanding the FDA Process
As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight. But, for the highest-risk Class III devices, the FDA uses the most stringent Regulatory control – the Premarket Approval Process.