FDA Extends Comment Period for Refurbishing Medical Devices

The FDA is extending a comment period to June 3 for its proposal to redefine third-party servicing for medical devices.

The FDA had asked industry for feedback in March on the challenges third-party entities face in maintaining or restoring devices to their original or current specifications. The input will be used to redefine terms related to refurbishing devices.

The March 4 notice came after the FDA heard stakeholders’ concerns that third-party entities may not have expertise to maintain or restore devices to original specifications and that the work may not be adequately documented. The document singled out endoscopes as a particular area of concern.

The FDA will hold a public meeting in 2016 to discuss comments submitted to the docket. — Joya Patel


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