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Regulatory Focus™ > News Articles > FDA (and 27 News Articles) Show us why 3D Printing Will Challenge Regulators for Decades to Come

FDA (and 27 News Articles) Show us why 3D Printing Will Challenge Regulators for Decades to Come

Posted 21 August 2013 | By Alexander Gaffney, RAC

There's been no shortage of stories in the media this year about three-dimensional (3D) printing, a process in which specialized printers can build products by layering polymers or other materials.

The applications are seemingly endless, as conceivably anyone with a sufficiently advanced printer could download a template for a product and then print it for their own consumption. But while the media has mostly been obsessively focused on the idea of 3D-printed weapons, US regulators and some media outlets are now asking themselves another question: How do you effectively regulate 3D-printed medical devices?

Tip of the Iceberg

The question is on full display in a recent FDA Voice blog posting by Steven Pollack and James Coburn, both with the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).

As both readily note, 3D-printed devices have already been produced in recent months, a printed skull implant and a bioresorbable device used to save a young boy among them. In both cases, doctors sought and received emergency investigational device exemption clearance from FDA.

But in all likelihood, this is only the tip of the regulatory iceberg. FDA notes in the posting that its Office of Science and Engineering laboratories are already working to investigate how the technology will affect the future of device manufacturing, and CDRH's Functional Performance and Device Use Laboratory is developing and adapting computer modeling methods to help determine how small design changes could affect the safety of a device. And at the Laboratory for Solid Mechanics, FDA said it is investigating the materials used in the printing process and how those might affect durability and strength of building materials.

Further Questions

But while the post notes much that FDA is doing, it also raises an enormous number of questions about the future of medical device regulation.

Take, for example, a prosthetic hand featured in the post. Made by a South African inventor, the hand "can now be printed for less than $100" in materials, FDA noted. As printing costs continue to fall, could more consumers use this as a way to avoid obtaining their medical devices through medical professionals? Many Class I devices seem ripe for 3D replacements-crutches and casts in particular-and even more advanced prosthetic devices could soon be able to be made entirely in the comfort of one's own home.

All of this, then, raises an important question: What role will FDA play in the future of 3D printing?

After all, if a 3D printer is making a medical device, it technically falls under the manufacturing regulations of 21 CFR 820 (Quality Systems Regulations). However, a precedent here may be FDA's regulatory approach toward smartphones, which-even when running a medical app approved by the agency-is not seen as a medical device due to its myriad other uses.

And the medical device itself would fall under other regulations, such as premarket notification (510(k)) and premarket approval (PMA), meaning printers could find themselves running afoul of the Federal Food, Drug and Cosmetic Act, particularly if the products are ever sold.

But if source files for printing devices can be freely shared over the Internet, will FDA be able to sufficiently regulate these devices?

In the future, it may not just be devices the agency needs to worry about either. 3D printing applications have also begun to emerge for printed cells, tissue products and even organs. And according to some reports, even the US space agency NASA is looking at applications on how 3D printing could be used to make medicines for manned deep-space missions, meaning we could soon see similar civilian applications as well.

One thing seems certain: This is one space to diligently watch for its regulatory implications.

Additional Reading

This issue has fascinated your editor for a while now-long enough that he's been collecting lots of articles on the subject. Here, for your perusal, are 27 of the most interesting ones related to biomedical sciences-devices, biologics, drugs and combination products that could one day be the future (or the end) of product regulation.

  1. MedGadget: 3D Printer Helps Amateur Prosthetic Designers Build the RoboHand
  2. The Guardian: 4D-printing: from self-assembling chairs to cancer-fighting robots
  3. Huffington Post: Doctors Save Life Of Kaiba Gionfriddo, Ohio Boy, By 3-D 'Printing' Him An Airway Tube
  4. MDDI: If You Can 3-D Print a Gun, Why Not a Medical Device?
  5. National Geographic: 3-D Printer Makes Synthetic Tissues from Watery Drops
  6. CBS: Airway made by 3D printer saves infant's life - CBS News
  7. Scientific American: 3-D Printed Windpipe Gives Infant Breath of Life: Scientific American
  8. MedGadget: Oxford Creates New Type of 3D Printed Tissue
  9. MedGadget: 3D Printer Helps Amateur Prosthetic Designers Build the RoboHand
  10. MDDI: 3-D Printing Giants Combine as Stratasys Acquires MakerBot
  11. Medical News Today: Novel Application Of 3D Printing Could Enable The Development Of Miniaturized Medical Implants
  12. Huffington Post: 3D Printed Cell Technique Allows Material To Mimic Human-Like Tissue
  13. NPR: 3-D Printer Brings Dexterity To Children With No Fingers
  14. MDDI: How 3-D Printing Is Helping Doctors Do Their Jobs
  15. Tennessean: NovaCopy uses 3-D printing to save duck's life
  16. In-Pharma Technologist: Pills in Spaaace: 3D printing could make meds for Mars says NASA
  17. In-Pharma Technologist: 3D Printing Could Create Better Pills say UK Researchers
  18. NPR: 3-D Casts So Cool That You'll Almost Want To Break A Bone
  19. MedCity News: Wow of the week: Could a 3-D printed cast become a disruptive medical device?
  20. USA Today: Doctors use 3-D printer to custom-design implant for baby
  21. Fast Co-Design We're Getting Close To 3-D Printing For Organs
  22. EurekAlert: 3-D-printed splint saves infant's life
  23. NYTimes: Printing Out a Biological Machine
  24. University of Michigan: Baby's life saved with groundbreaking 3D printed device
  25. Gizmodo: How a 3D Printer Helped a Child Breathe Again
  26. Think Progress: The Five Most Promising Uses Of 3D Printing In Medicine
  27. CNN: Think 3-D printing is cool? Try 4-D

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