Diagnostic Imaging: MITA Calls for FDA Registration for Third-Party Medical Device Servicers

Feb 10, 2021, 00:00 AM

Third-party vendors who service medical equipment and devices should be held to the same standards levied by the U.S. Food & Drug Administration (FDA) as all service groups, said the Medical Imaging & Technology Alliance (MITA).

In its new white paper, “Understanding Accountability in Medical Device Servicing,” MITA outlined a problem where third-party services function in a “regulatory grey area.” The FDA maintains regulatory oversight of original equipment manufacturers (OEM), but third-party business do not have to abide by the same accountability mechanisms, raising red flags for patient safety and device performance.

Click here to see the full article on the Diagnostic Imaging website.