Image courtesy of (printing the human body)

How will the FDA regulate 3D printing and rapid prototyping?

Posted on October 6, 2013 · Posted in Medical Device Trends

As biotechnology continues to advance into the areas of cellular printing, it is becoming ever more difficult for the FDA to determine how these machines and the produced products will be regulated. It’s especially complex considering these machines are producing custom products “of one”.

Let’s face it, if we all had access to custom “printed” dental, organ or joint products, that could feasibly eliminate the need to produce masses of units at one time and would eliminate wait times for donor organs.

Until the time comes when printing medical items in your surgeon’s or physician’s office is common practice (FYI: It’s happening in dental offices now), read how the FDA is planning to regulate rapid prototyping and “manufactured units of one”. Guidance is expected within the next two years.