The United States Food & Drug Administration (FDA) is the regulatory body governing the safety of American’s health when it comes to pharmaceuticals, food and medical devices. It is, perhaps, the epitome of the double edged sword that is strict (sometimes unnecessarily prohibitive) regulation versus public safety. Regardless of your opinions on that debate, the FDA is now publicly acknowledging 3D printing, specifically in its role as a method of manufacture for medical devices.
Somewhat behind the curve, this public body will host a public workshop later this year (8th and 9th October – so no rush then!) entitled: ‘Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.’ The stated purpose of the workshop, which also invites comments from people unable to attend, “to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3D printing” in order to garner “input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”
Highlighting the positive attributes of 3D printing for cost-effectively producing patient-specific devices, the FDA also highlights the issues it faces, specifically process verification and validation, for single item / small run production processes. I have had numerous conversations along these lines, and seen at least as many presentations on the topic, over many years and as far back as the late 90’s, most notably with Richard Bibb who then worked at PDR, so I really do think the FDA is rather late to the table with this workshop. That said, they are making the right noises in terms of having an open and ongoing discussion with stakeholders that include researchers, scientists, and engineers, “to foster innovation with a transparent process and shared expectations.” Late or not, the FDA is at least appreciating that 3D printing is here to stay and it is not just a fad.
I was particularly interested to note that the workshop will not address specific printing technologies or medical device types, which would require eons of time, not the two days that have been set aside to discuss the overall technical challenges of 3D printing medical devices. The goal is to generate ideas that will “facilitate [the] development of new draft guidances and/or standards for additive manufacturing of medical devices.”
Now they just need to wrap their heads around 3D printing pharmaceuticals and food …… or is that too soon?
The public workshop will be held on October 8 and 9, 2014, from 8 am to 5 pm at the FDA’s White Oak Campus in Maryland. Public transcripts of the event will subsequently be made available.
