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Ortho Companies Emphasize Software For Patient-Matched Instrumentation Guidance

Orthopedic device companies say FDA should provide guidance on how software used to design and implant patient-matched instrumentation could be regulated. They note that while physician experience and training is the key factor for surgeries using such devices, software is critical to how patient data is collected, evaluated and shared among surgeons and pre-operative personnel.

Companies say FDA should focus on software requirements for patient-matched instruments for orthopedic surgeries as the agency works to develop a draft guidance for the product category.

FDA's device center asked industry about how patient matched devices are designed and implanted in orthopedic surgeries earlier this year as part of its fiscal year 2015 guidance

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