Story after story illustrates the power and popularity of 3D printing in the medical field.  Fueled by the ability to customize solutions to specific patients, providers are using the revolutionary technology to create and improve a range of medical devices, surgical guides, designer drugs, and body implants.  The wide adoption of health-related additive manufacturing initiatives has left the FDA scrambling to respond.  In late October, 2014, RapidMade participated in an FDA-sponsored forum of stakeholders to discuss their concerns and consider best practices.  Since then, it appears that the FDA has backed away from implementing industry-wide regulatory guidelines and instead chosen to review and decide each product on a case-by-case basis using existing 510K and emergency use regulations.  

At least one source, Maya Eckstein, argues the current tactic does not sufficiently address an ever-increasing number of issues that are surfacing...

Unanswered questions include:

How will FDA treat non-traditional device “manufacturers,” such as hospitals?
Will FDA regulate 3D printers as medical devices? Or, will FDA only concern itself with 3D-printed products?
Will a manufacturer’s sharing of its design files for a 3D-printed product constitute promotion of the product? If so, will manufacturers be obliged to share risk information whenever they share design files?
When will FDA consider a 3D-printed device to be a “custom device”? Will such 3D-printed custom devices be exempt from premarket approval requirements and mandatory performance standards?
How will FDA execute its inspection program? How will quality systems and good manufacturing practice requirements be applied to the 3D printing of drugs and devices?

Another unknown is whether the FDA will attempt to regulate non-profit organizations like e-NABLE which use a network of unregulated makers to print and distribute low-cost prostheses to needy children and adults.

Clearly the key will be providing enough regulatory oversight to ensure patient safety without becoming overly bureaucratic and cumbersome.