Medical device manufacturers want more information from FDA about 3D printing

25 October 2016

Medical device manufacturers want the US Food and Drug Administration (FDA) to provide more clarity on its guidance on 3D printing.

The FDA has approved 85 3D printed devices as of December 2015 and device manufacturers are calling on the FDA to be more specific on guidelines, operating procedures, regulatory issues and a host of other criteria.

Earlier in 2016, FDA provided a "leap-frog" draft guidance outlining the agency's initial thinking about technical considerations for the manufacture of 3D printed devices, in addition to general information on characterising and validating such devices. The guidance also focused on the design, manufacturing and testing of 3D printed devices.

Trade group the Advanced Medical Technology Association (AdvaMed) submitted three general comments to the FDA and released the following statement: “Clarifying regulatory expectations for point-of-care establishments in this guidance is of paramount importance.”



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