No New Regulations Needed For Third-Party Servicers Of Devices, FDA Says

16 May 2018

• By Sue Darcey

There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."

Maintenance engineer repairing and checking CT scanner machine in the hospital. Technology Concept.

Despite repeated assertions by original equipment manufacturers that US FDA needs to impose quality and reporting requirements on third-party organizations that provide services and maintenance for medtech equipment, the agency said in a new report that “the current available evidence” does not justify extra rules.

“The objective evidence indicates that many OEMs and third-party entities provide high quality, safe and effective servicing of medical devices,”...