The long-awaited FDA draft guidance on 3-D printing, known formally as additive manufacturing (AM), doesn't mean the cutting edge technology will be hitting drugstores in your neighborhood soon, but it is a significant next step for medical applications of the technique.

"For medical devices, AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient’s own medical imaging," the agency noted in its statement, adding that another advantage is the ease in fabricating complex geometric structures, which allows "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 agency also advised that its announcement is "leapfrog guidance," and it explained that these "are intended to serve as a mechanism by which the agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development," warning, in addition, that its "recommendations may change as more information becomes available."
As such, its recommendations are not "legally enforceable," it noted, explaining that "the use of the word 'should' in this latest announcement means that 'something is suggested or recommended, but not required.'"

The technology is already in use with over 85 FDA applications approved for "low-level medical devices," according to 3Dprint.com.

And in March the agency gave its okay to a first-ever application – Aprecia's SPRITAM, a 3-D printed drug for epilepsy. That drug's 3-D technology permits it to disintegrate in a patient's mouth.

The FDA explained that it felt it important to release its initial thoughts at this time because "rapid technological advancements and increased availability of AM fabrication equipment are encouraging increased investment in the technology and its increased use in medical devices."

The new draft guidance, however, doesn't cover AM-created biologics. "Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways," it stated.

The guidance came as a result of a public workshop in 2014 addressing issues arising from the medical application of 3-D printing, including the vital importance of material control.

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