FDA draft guidance for 3D printed medical devices
The FDA has unveiled new draft guidance for 3-D printing, laying out its thoughts on the technology and device regulation as more med tech companies jump into the fast-growing field.
In an effort to make FDA testing processes easier for all parties involved and enable developers to prepare as best as possible, they have now finally released a long-awaited draft guidance for 3D printed medical devices.
3-D printing “has the advantage of facilitating the creation of anatomically matched devices and surgical instrumentation by using a patient’s own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches,” the FDA said.
Here below you can the guidance documents:
