Tag Archives: regulation

FDA Released Draft Guidance on 3D Printing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The FDA recently released draft guidance for those using 3D printing (also known as “additive manufacturing”) to create or modify medical devices.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Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only.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“Although the draft guidance is a start, there are still many unresolved regulatory issues that need to be addressed, especially as the technology continues to evolve and more innovative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

FDA On Social Media: Time to Pay Attention, Take Two

FDASM Campus Forum Feb 16SL: Virtual Ability: Introduction to the FDASM
FDASM Transcripts Wordle23andMe, reduced

Remember five or so years ago when we put together a campus event about the FDA call for input on social media guidance? I blogged about it a lot. I’m sure many of you are already aware of the new FDA Social Media draft guidelines that were, at long last, released last month.

Recently I heard an interview with David Harlow about the new draft guidelines. I was very surprised when I heard him say that the FDA sent a warning letter to a company for clicking “like” on a patient’s Facebook post. That seemed a bit over the top to me, although I confess I haven’t yet found the original warning letter. I had been inclined to just trust that after thinking about this so long, the FDA would come out with something helpful, but it sounds like that isn’t what happened. Responses from the drug companies seem to be along the lines of just avoiding the whole problem, if the FDA is going to be so challenging and confrontational. Responses from folk working actively in HCSM are that the FDA is not getting the point or purpose of social media engagement, and that the guidelines are sufficiently restrictive as to make it impossible to adhere to the specifications.

I know that I need to know more about this, and I believe that readers of this blog do also. The period for public comment is over in September, so there is very little time to respond. My fault — I should have paid closer attention to this sooner.

BACKGROUND

For context, I’d like to first remind people of the comments we filed with the FDA during the original call for comments. Where it sounds like things have broken down is with respect to our third point (#3): “the potential to be perceived as interfering with free speech of the public or creating an undue and insupportable burden for industry and the healthcare communities,” and to the concerns about use of social media within an educational framework.


FDA-2009-N-0441 Docket Comments, University of Michigan Public Forum: http://www.slideshare.net/umhealthscienceslibraries/fda2009n0441-docket-comments-university-of-michigan-public-forum

Here are my slides from five years ago, just to provide context for the background of the conversation.


FDA Social Media Guidelines – Introduction http://www.slideshare.net/umhealthscienceslibraries/fda-social-media-guidelines-introduction

Now, here are some links about where things stand today, plus the presentation by David Harlow, which I encourage you to watch.

DAVID HARLOW


FDA Social Media Changes that May Affect Healthcare https://www.youtube.com/watch?v=aEutmz0kFsM

#FDAsm – FDA Releases Draft Social Media Guidance Five Years After Public Hearing http://www.healthblawg.com/2014/06/fdasm-fda-releases-draft-social-media-guidance-five-years-after-public-hearing.html

FDA Social Media Guidance – Hangout on Air http://www.healthblawg.com/2014/07/fda-social-media-guidance-hangout-on-air.html

PUBLIC HEARINGS

2009: Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm

July 10, 2014: Social Media Guidance Webinar – July 10, 2014: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm403810.htm

FDA ANNOUNCEMENT

FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internet-communications-about-medical-products-designed-with-patients-in-mind/

Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/html/2014-14221.htm

NOTE: This is where to file comments >>
[Docket No. FDA-2014-D-0447] Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability https://www.federalregister.gov/articles/2014/06/18/2014-14221/draft-guidance-for-industry-on-internetsocial-media-platforms-correcting-independent-third-party

DRAFT GUIDELINES

Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf

Guidance for Industry : Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf

Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Jan 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf