3D medical devices at the Point of Care

General
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The FDA has started to discuss the implementation of 3D medical devices at the POC. There are more questions than answers so far.
download (fda.gov)

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Thank you for finding this. they seem to be very focused on the point of care for patient-customised things, but it is very interesting that one of the models they are thinking about is that the healthcare facility assumes the whole design, manufacture and certification process (scenario 3 of fig 1).

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This discussion reminds me to what happened with laboratory developed test (home brew tests). These are high complexity test that are designed, manufactured, and used within a single laboratory. It took a very long time for FDA to suggest that it should be regulated.

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