The US Food and Drug Administration received frequent complaints about Essure, a permanent birth-control mechanism. 

This begs the question: Why are approved devices creating serious safety concerns on the market? It is clear that strict regulatory oversight cannot prevent the rise in malfunctioning medical devices. 

Are Your Customers Truly eXperiencing Your Implementations? The device manufacturer must ensure that all safety, quality, and effectiveness parameters are met by following regulations.

Therefore, the clinical data from these studies will not be sufficient to draw valid conclusions about device safety and performance. Bayer should have done a complete randomized, blinded clinical study instead. 

This should not be a general answer. It should be answered using business-based decision-making. Understanding the product's features from both profit and risk perspectives is key to the value proposition for medical devices. 

Base customers for medical devices are patients and end-users, whose needs should be given higher priority than regulatory rules.

The ISO14971 risk management standard is an effective business tool that can be applied to medical devices. This standard applies to all medical devices, regardless of their risk classification or approval methods. 

All device manufacturers must take all reasonable steps to ensure that the risk level is as low as possible. Approval pathways for devices with lower risk are not designed to provide relief from risk reduction measures. 

If a full clinical trial is necessary to determine the device's risk/benefit profile, this should be completed along with regulatory processes. A 510(k)approval process should not be less valid than a PMA.