The U.S. Food and Drug Administration (FDA) recently published draft guidance
regarding the 3D printing of drugs and medical devices. The guidance is
long overdue, as the agency has already cleared more than 80 medical devices
that used 3D printing along with one prescription drug.
3D printers now make it possible to create a new object by downloading
a design file and hitting “print.” The technology is increasingly
being used in the pharmaceutical and medical device industries, particularly
to develop personalized drugs, prosthetics, and other medical products.
While 3D technology holds great promise, it also poses regulatory challenges.
To date, all FDA approvals have been issued through traditional pathways.
However, 3D printed medications and devices pose a range of unique safety concerns.
To address 3D printing issues, the FDA recently issued a
draft guidance for Technical Considerations for Additive Manufactured Devices. According to the agency, the draft guidance is a “leap-frog”
guidance, which means it is intended to serve as a mechanism by which
the FDA can share initial thoughts regarding the emerging technology.
As highlighted by the FDA, the guidance “represents the Agency's
initial thinking, and our recommendations may change as more information
The FDA guidance specifically addresses the technical considerations associated
with 3D printing and makes recommendations for design, manufacturing,
and testing of medical devices that include at least one fabrication step
using “additive manufacturing.” The term refers to a process
that builds an object by iteratively building 2-dimensional (2D) layers
and joining each to the layer below.
The FDA guidance is divided into two parts. The first section of the guidance
addresses design and manufacturing considerations. It specifically provides
technical considerations that should be addressed as part of fulfilling
Quality System requirements for manufacturing a device, as determined
by its regulatory classification or regulation to which it is subject.
The second section covers device testing considerations. It describes
the type of information that should be provided in premarket notification
submissions [510(k)], premarket approval (PMA) applications, and other
applications for a 3D printed device.
As San Diego product liability attorneys, we will be closely tracking the
FDA’s efforts in the area of 3D printing. We are hopeful that the
new technology can revolutionize the way medical devices are made without
compromising patient safety.
If you or someone you care about has suffered serious harm due to a dangerous
or defective drug or medical device, don’t hesitate to contact
a San Diego injury lawyer at the Law Offices of Robert Vaage for a free
consultation. Our legal team has successfully represented clients against
manufacturers and distributors of medical devices for more than 30 years.