Tag Archives: guidance

FDA Released Draft Guidance on 3D Printing

Boatloads of people and a brain computer interface — #3Dprinting & #Robohand folk at #MakeHealth

The FDA recently released draft guidance for those using 3D printing (also known as “additive manufacturing”) to create or modify medical devices.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Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only.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.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

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.

Here, at the University of Michigan, most of the press we’ve gotten around 3D and 4D printing has related to saving babies (in multiple ways) and making surgeries safer.

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“Although the draft guidance is a start, there are still many unresolved regulatory issues that need to be addressed, especially as the technology continues to evolve and more innovative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.”

AND

“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.

Additional reading

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

Concerns & Clarification on the FDA Guidelines for Social Media (#FDAsm)

FDASM: FDA on Social Media

Last Tuesday afternoon, there was a Twitter chat on the new FDA guidance on social media that was hosted by the medical librarians group (#MedLibs), but which engaged an audience that also included healthcare professionals, lawyers, and communication specialists. It was a very interesting chat that touched on concerns, assumptions, misunderstandings, clarifications, and resources. You will find many of these excerpted from the full conversation and highlighted below. First, though, here is a high level summary.

Concerns included the potentail for a “chilling effect” that might impact on education, innovation, professional and patient public communications, research and clinical trial recruitment; responsibility (who is responsible for what/when/where/how with respect to health social media communications); effectiveness of social media controls for their intended purposes and the costs/benefit assessments; the role of identity, honesty, and transparency in health social media communication; and whether the guidelines will promote inclusion or foster exclusion of relevant voices in useful conversations.

Clarifications sought: plain language summaries of the guidelines; description of the potential and expected impacts on various communities of practice, including health education and patients; the relationship and responsibilities of employers and employees in their social media identity management and communications; and the issue off-label use conversations outside of pharma entities.

Clarifications which appeared during the chat (but which are note from the FDA, and therefore not the authoritative word with respect to these issues): who is covered by the guidance; community and individual efforts to create plain language distillations of the guidance; context; and a reminder that freedom of speech does not equal freedom of consequences for that speech.

For Medical Librarians: role for medical librarians in supporting and demonstrating best practices in Twitter chats; role for medical librarians in supporting education around the FDA’s guidance for their institutions as well as for patients and the public; and a caution about medical librarians being potentially excluded from social media as part institutional image controls as well as potentially as an impact of the guidance.

Takeaways: how to format an FDA-style tweet; avoid creating branded accounts for free conversation; encourage individuals to create personal accounts that are not branded and are distinct from the brand; consider correction of health misinformation as an opportunity; avoid perception of “practicing medicine” on social media, but discussions are alright; consider commenting on the FDA draft guidelines before September 17.

In addition, the conversation included discussion of best practices for identifying tweets as representing personal opinion, as well as a rich collection of resources.

CONCERNS

CLARIFICATION NEEDED

CLARIFICATION RECEIVED

FOR MEDICAL LIBRARIANS

TAKEAWAYS

FURTHER QUESTIONS

RESOURCES