FDA Rejects New Device Regulation for Third-Party Servicers

May 22, 2018

The FDA rejected a push to impose additional regulations on third-party servicers of medical devices, saying there is insufficient evidence to justify imposing new regulatory requirements.

In a report released May 15, the agency calls for developing voluntary standards rather than mandating specific regulations.

This “reflects the agency’s belief that the current processes in place at servicing facilities support continued quality, safety, and effectiveness of medical devices that undergo servicing,” FDA spokesperson Deborah Kotz told FDAnews.

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