May 11, 2016
One of the most explosive areas of growth for additive manufacturing (AM) is its expansion into the medical field. The technology is used in an increasing number of applications, including prosthetics, implants, medical devices and even drug manufacturing. This one aspect of AM may yet prove to be the most valuable contributor to improving lives around the world.
While the FDA had approved both 3D printed medical devices and drugs, it hadn’t really offered its views on clear guidance. The government agency held an AM workshop in late 2014 where it discussed the future of medical 3D printing with a number of stakeholders as part of its investigation into the technology. Continued research has, at last, resulted in a draft document providing guidance for 3D printed medical devices titled “Technical Considerations for Additive Manufactured Devices.”
The document begins by making it clear that the contents are still in draft form, which the FDA refers to as “leap-frog guidance.”
“… leap frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leap-frog guidance represents the Agency’s initial thinking, and our recommendations may change as more information becomes available.”
According to the FDA, the document can be broken down into two general areas of information; design and manufacturing considerations, and device testing information. The draft offers a comprehensive overview of AM, beginning with design and running through testing, quality data and material considerations. It is clear that the document is intended for a variety of audiences and includes what is essentially an executive summary of AM, along with more technical details pertinent to the actual manufacturing of 3D printed medical devices.
Unsurprisingly, a good half of the draft concerns itself and its readers with quality control and testing. The FDA offers suggestions on manufacturing methodology that is most likely to result in quality outcomes, including the manner in which AM systems are operated and quality data is collected. Section VI lays out FDA’s expectations for device testing considerations.
“The type and amount of data to support a substantial equivalence determination or approval will vary depending on the intended use, risk profile, and classification and/or regulation for the device type. In addition, the type of information needed for a device made through AM may also depend on a variety of factors, including, but not limited to, whether it is an implant, load bearing, and/or available in pre-specified standard sizes or is patient-matched. Not all considerations described will be applicable to a single device, given the variety of devices that can be made by AM and the AM technologies available.”
Throughout the draft, the FDA is constantly at pains to remind readers the agency is always available to answer questions. It encourages medical device manufacturers to work closely with the FDA in order to achieve the highest quality product possible.
Below you’ll find a short video about the first FDA approved 3D printed drug.