by: Jeff S. Gibson, Attorney
A considerable amount of buzz has surrounded the use of 3-D printing technology lately. Forbes magazine recently reported on Wall Street investors’ increasing interests in 3-D printing companies and the anticipated growth of the industry. Medical science has also reported stories of lives being saved or improved by the use of 3-D printed medical devices. In one case, the life of a 3-month old boy with a rare bronchial condition was saved by the use of a 3-D printed stent. Other medical devices that have been manufactured using 3-D printers include prosthetics, skull implants, and hearing aids.
Two questions that probably come to mind are What is 3-D printing? and Does the FDA regulate these devices?
3-D printing has been around since the mid-1980s. Unlike traditional manufacturing, 3-D printing uses a method of adding layers of material to create a model or prototype. The material used can range from liquid to sheet material. The advantage of 3-D printing over traditional manufacturing is customization and speed. Technology has made it possible for manufacturers to create products with 3-D printers that were previously impossible to imagine.
The FDA is responsible for the regulation of medical devices marketed in the United States, including those manufactured using 3-D print technology. Here are a few key things to know about how some medical devices are approved.
Emergency Use Authorization (EUA) and Investigational Device Exemption (IDE)
The Center for Devices and Radiological Health (CDRH) is the division of the FDA that is responsible for providing the premarket approval, overseeing the manufacturing, and monitoring the performance and safety of medical devices.
Two ways that a new medical device can be made available for patient use include an investigational device exemption (IDE) and an emergency use authorization (EUA). The FDA requires a specific set of guidelines be followed in order to consider a medical device for patient use. One phase of the approval includes a clinical study process to measure safety and effectiveness. While the device is in the investigational testing stage, it is possible for the FDA to grant an exemption to allow the device to be used in a human patient based on a healthcare provider’s request and stringent review.
An emergency use authorization (EUA) is another way that a new medical device may be approved for use. Regardless of its stage in the clinical trial process, an investigational device can receive emergency authorization if the patient is in a life-threatening situation. In both cases, patients need to be made aware of the possible risks associated with the use of the device.
Future of Healthcare
On August 18, 2013, the FDA updated the system it uses to process IDE and EUA requests in an effort to improve patient access to new medical devices. This updated system may give healthcare professionals quicker approval to use customized 3-D printed medical devices to save lives and provide better care of patients. As this technology grows and becomes more readily available for healthcare providers, these types of medical devices can have a big impact on the way that diseases, illnesses, and injuries are treated.
Regardless of the capabilities of 3-D printing in the creation of medical devices, it is important that healthcare providers and FDA maintain a vigilant watch over the risks associated with medical devices and ensure patient safety remains a priority.