Since we are now fully comfortable with "smart"
everything, it should be no surprise that 3D printing has taken center stage in the tech
world. It's easy to imagine 3D-printed machine parts, prototype
models, or even toys, but it might be harder to accept 3D-printed foods, implantable medical devices, cosmetics, drugs, and even
human tissue. Too futuristic? Not really. The technology to
3D-print, U.S. Food and Drug Administration
("FDA")-regulated products is, in large part, already
here and rapidly progressing.
Yet, as technology continues to develop, questions arise as to
whether, and how, the FDA regulatory framework will keep pace to
impose the same safety, quality, and efficacy standards to
3D-printed foods, drugs, cosmetics, and medical devices that
currently apply to traditionally manufactured goods. How FDA
chooses to deal with 3D-printed products will significantly impact
not only barriers to market-entry, but also post-marketing
enforcement risks. Similarly,
