Regarding the USA FDA approval:

Before being commercially marketed in the United States, medical systems must first be approved by the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (FDA). In order to obtain FDA approval, the applying company must perform a clinical study to prove the safety and effectiveness of the system on patients and must also comply with various Federal and State regulations.

In general, the type of clinical studies submitted for Pre-Market Approval (PMA) must meet certain statistical requirements and follow-up procedures to ensure the effective and safe use of the medical equipment.

With regard to new medical technologies in particular, it can take months or even years to complete the PMA approval process. For example, the FDA clinical trial using the OssaTron® to treat Plantar Fasciitis was submitted on December 30, 1999 and the PMA was awarded on October 20, 2000; the Lateral Epicondylitis clinical trial protocol was submitted to FDA for PMA on November 5, 2001 but approval was not granted until March 14, 2003.

It is important to understand that a PMA is limited to a specific medical procedure with a specific device and thus, generally, the entire PMA process must be repeated for each additional indication for which the device will be used.

Furthermore the CDRH does not classify or rank technology; it simply grants the “green light” for the company to market the defined system for the particular application in the United States. The CDRH has no connection with US health insurance companies nor does it have any control over remuneration for medical procedures, which is a separate issue.