The FDA recently released draft guidance for those using 3D printing (also known as “additive manufacturing”) to create or modify medical devices.
Technical Considerations for Additive Manufactured Devices
Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only.
Document issued on May 10, 2016.
This is a pretty interesting happening, and particularly interesting in the context of the maker movement, #DIYability, #InventHealth, #MakerNurse, and #MakeHealth. These are all concepts or movements driving the improvement of health and healthcare through engagement with the general public. This is where a lot of patients and the general public use creativity, insight, experience, and often various technologies such as 3D printing in order to craft custom solutions to interesting health challenges.
So, will the FDA guidance impact on people trying to make stuff at home, at work, in the hospital? Possibly. Actually, according to the strict interpretation of the current definitions, it sounds pretty likely. (Please, note, I am not a lawyer!) Here is one section on that aspect.
“Point-of-care device manufacturing may raise additional technical considerations. The recommendations in this guidance should supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.”
So, this is talking about point-of-care, which would include pretty much all the maker communities I was mentioning above, but it’s really really vague. I’m not the only person who thinks so.
“Although the draft guidance is a start, there are still many unresolved regulatory issues that need to be addressed, especially as the technology continues to evolve and more innovative products are brought to market. One still-pressing, unanswered regulatory issue associated with 3D printing is how the FDA intends to approach non-traditional device manufacturers. As background, under the existing FDA regulatory framework, a manufacturer is defined broadly to include “any person who designs, manufactures, fabricates, assembles, or processes a finished device.” As 3D printers become increasingly accessible, a person (or entity) with a 3D printer does not need the financial capital, infrastructure, or resources historically associated with traditional manufacturing operations. While the draft guidance acknowledges point-of-care manufacturing, it does not provide much discussion on non-traditional entities, such as healthcare providers and suppliers becoming “manufacturers” of medical devices. … We also do not know how the FDA intends to resolve the legal and regulatory issues associated with point-of-care manufacturing.”
Matt Jackson, Kevin Madagan. FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown http://www.meddeviceonline.com/doc/fda-s-d-printing-draft-guidance-leaves-much-unresolved-even-more-unknown-0001
The next thing they mention, in the same paragraph, is biofabrication (which technically is less about making devices and more about 3d printing with biological “ink,” living cells, biomaterials, and such).
“In addition, this guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM. Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways. Therefore, all AM questions pertaining to products containing biologics, cells or tissues should be directed to the Center for Biologics Evaluation and Research (CBER).”
I’m actually relieved that they are leaving biofabrication alone for now, but it is not going to go away forever (nor should it). For people working at the intersectional spaces of 3D printing, where it combines with biologics, electronics, programmables, smart materials, and other materials with interactive potential, there is a possibility that content from this guidance may interact in unexpected ways with the other side of the work they are trying to do.
Here’s the good news.
“This draft guidance is a 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.”
“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”
So, don’t worry TOO MUCH just yet, but do please read this, consider how it might impact on work happening in your community, and consider replying to the draft guidance or filing comments. You may submit comments on the Technical Considerations for Additive Manufactured Devices Draft Guidance until August 8, 2016.
3D Printing of Medical Devices http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm
FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices http://www.raps.org/Regulatory-Focus/News/2016/05/09/24901/FDA-Issues-Long-Awaited-3D-Printing-Guidance-for-Medical-Devices/
The FDA Releases Draft Guidance for Industry & Food & Drug Administration Staff Regarding 3D Printing https://3dprint.com/133570/fda-draft-guidance-3d-printing/
FDA releases long-awaited draft guidance for 3D printed medical devices http://www.3ders.org/articles/20160510-fda-releases-long-awaited-draft-guidance-for-3d-printed-medical-devices.html