Bonnie I. Scott, an Associate in the Health Care and Life Sciences practice, in the firm's Washington, DC, office, authored an article in Houston Medical Times, titled “Legal Health: What’s New in 3-D Printing?”
Following is an excerpt (see below to download the full article):
As we move in 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.
In touch with this trend, in October 2014, the U.S. Food and Drug Administration (FDA) engaged industry stakeholders to discuss technical considerations surrounding 3-D printed products. However, this workshop was strictly focused on technical issues; “regulatory policy” was slated to be “a whole separate discussion.” Indeed 3-D printing presents many regulatory questions that currently translate to regulatory uncertainty. Still, leading innovators seem to be moving full steam ahead in the development of various 3-D printed technologies because of the value they offer patients. With the right kind of regulation, the “personalized medicine” these 3-D printers can provide could greatly advance the public health. Accordingly, many are hoping that FDA will soon move past technical discussions and work with stakeholders to develop the best possible regulatory framework to expand access to safe and effective 3-D printed devices.
