The US Food and Drug Administration (FDA) has released a new draft containing guidelines for medical device manufacturers who build 3D printed devices, also known as additive manufacturing (AM). The document was issued on May 10th, 2016.

3D printing has come a long way since its inception and the world of medical healthcare has seen many innovative 3D creations. The FDA has approved more than 85 applications for 3D printed devices, although they are for low-risk products. In March of 2016, the FDA approved the first ever 3D printed drug, Aprecia’s SPRITAM, for epileptic seizures. The drug offered rapid absorption, making it a fast-acting drug and easier to swallow.

Researchers are also looking to introduce 3D printing to the world of biologics, which involves cell and tissue reproduction. However, these guidelines are currently not addressing point-of-care devices as they may raise additional technical difficulties.

It is important to note that these are leapfrog guidelines, meaning that this is an initial plan that will likely be of public health importance in the early stages of product development, but requirements may change as more information is made available. To make the process more efficient, FDA is appealing manufacturers to communicate with the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).

The FDA’s draft proposal is looking to streamline the complete 3D manufacturing process. The guidelines are meant to provide manufacturers an insight into the thought process of the agency when the idea is conceptualized. These regulations will provide the technical aspects that need to be considered during the initial stages in order to comply with the agency’s rules and regulations.

While additive manufacturing (AM) is in its initial stages, its future applications and capabilities are endless. Hence, harnessing its technology using characterization, validation and verification poses quite a few challenges

The FDA writes, “AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient’s own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches.”

According to the FDA, it first brainstormed the idea at a 2014 public workshop on challenges related to 3D printing. The major learning outcomes were the impact of 3D technology and post printing processes on the performance of the final product and the need for a set of robust guidelines for streamlining the 3D manufacturing process.

The FDA focused the guidelines on two aspects — design and manufacturing, testing and validation.

Design And Manufacturing

The FDA states that the guidelines will give the devices additional options for adhering to regulations, so that they perform as intended. It further acknowledges that since there are many complex layers to the 3D manufacturing process, manufacturers should clearly identify each step in the printing process from the initial idea to the finishing touches of the final product. Additionally, companies should make sure that all possible outcomes of the process are kept in mind. For example, the ratio of fresh to recycled powder can affect melting point, hence there can be a change in energy differential between the layers, potentially affecting the outcome.

Testing And Validation

The devices will be approved after judging their original intended use, risk assessment and classification. Approval depends on whether the device was custom made to a specific patient or mass produced, according to FDA.

For custom devices, manufacturing companies should give the parameter range which the device’s size can take. For simplicity, the FDA says that printed devices should essentially perform similarly to non-printed regular devices. All materials involved in the designing process should be considered when testing. Also, during mechanical testing, the orientation of the final product should be considered since it will be relative to the printer’s orientation.

The FDA wrote in their guideline document, “Since the mechanical properties of the device may be impacted by orientation and location, it is important to ensure that production processes are properly developed, conducted, controlled, and monitored to ensure devices or components are not adversely affected by fabrication orientation.”

Why Were The Guidelines Needed In The First Place?

Since the number of 3D manufacturing companies is rapidly increasing, set of rules and regulations that guided the companies on the manufacturing process is needed. Many healthcare devices are quite expensive and not readily available. Therefore, more and more manufacturers are looking towards 3D technology for cheaper alternatives that do not compromise on quality, practicality and functionality.

Since the massive influx of 3D printed devices, it is becoming increasingly hard for the FDA to keep a check and balance on all devices. Consequently, instead of correcting each device, they introduced a draft of guidelines for the manufactures to make healthcare more accessible for everyone.