Devices

Servicing/Remanufacturing White Paper, Workshop

FDA has issued a white paper and will hold a 12/10-11 public workshop to gather feedback and comments on the distinction between servicing and remanufacturing of medical devices. The white paper is intended to guide discussion at the workshop through the agency’s initial thoughts about guiding principles, a flowchart with accompanying text, a complementary approach for software, considerations for labeling, and examples.

The paper discusses servicing and remanufacturing activities performed on medical devices by original equipment manufacturers and third parties. It addresses activities performed on reusable devices that can be serviced, repaired, refurbished, maintained, and/or remanufactured.

FDA lists these guiding principles for discussion:

servicing does not significantly change a device’s safety or performance specifications;
evaluate whether any changes to a device require a new 510(k);
assess component/part/material dimensional and performance specifications;
employ a risk-based approach; and
adequately document decision-making.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome