What is the goal of the Streamlined PMA process?

The goal of the Streamlined PMA (Premarket Approval) process is to fast-track devices that utilize well-known technology, enhancing the efficiency of the approval process for products that have already established safety and effectiveness through previous approved devices. This approach recognizes that certain devices may not require the same level of extensive clinical data or rigorous scrutiny as entirely new and innovative medical devices.

By allowing for a more straightforward and accelerated pathway, this streamlined approach can facilitate quicker access to the market for devices that demonstrate safety and efficacy based on existing technologies. This ultimately benefits patients and healthcare providers by making reliable medical devices available sooner while still upholding necessary regulatory standards.

While there are other processes and options available for device approvals, the specific emphasis on recognized technology in the Streamlined PMA process serves to balance innovation with the need for timely access to essential medical products.