In the United States the development and approval processes for medical technology products and diagnostic devices vary depending on the class assigned to them. Class 1 and 2 products can be approved via the 510(k) process, while Class 3 requires a PMA process. PMA stands for "Premarket Approval Application". Class 3 includes applications for more serious treatments such as defibrillators, implants and dialysis products. A PMA process is much more complex, lengthy and cost-intensive than a 510(k) process. While the 510(k) method requires only safety and efficacy in comparison to a reference product, the PMA method requires monitored clinical trials with randomized patient groups. In addition, manufacturing infrastructure must be inspected and approved prior to approval.
Europe
In Europe, manufacturers themselves declare the conformity of their products. However, they must undergo a conformity assessment procedure comparable to an approval process. All medtech devices and equipment must bear the CE mark ("Communauté Européenne") for distribution in Europe. With this CE mark, the manufacturer declares that the product complies with all relevant EU directives. Once the CE mark has been obtained in one EU country, this generally applies to all other 28 member states. The CE mark is not a seal of quality, but merely an "administrative symbol".