China Food and Drug Administration Issues New Draft Guidance for 3D Printed Medical Devices

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Regulations make the world go ’round…especially when it comes to 3D printed medical devices. The US FDA released draft guidance in May 2016, seeking feedback and continuing to explore the technology. In December 2017, the FDA issued its guidance on medical 3D printed devices, a move with implications on business operations and one pointing to a growing focus on additive manufacturing for the agency. Looking outside the US, other parts of the world have their own regulations and guidance when it comes to medical 3D printing as the technology continues to be adopted around the globe.

Over in Asia, the China Food and Drug Administration (CFDA) formally approved the manufacture and use of 3D printed hip implants, specifically those manufactured with metal 3D printing technologies, back in 2015.

This month, the Chinese regulatory agency’s Center for Medical Device Evaluation (CMDE) announced that it had issued new draft guidance regarding regulatory requirements for the complex sector of 3D printed medical devices.

The newly published guidance by the agency’s medical device market regulators, titled “Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration,” is meant to answer industry questions in regards to how the CFDA will go about approaching the regulation, and registration requirements, of important 3D printed medical devices on the Chinese market.

In a translated quote, the introduction to the new guidance states, “This guidance is intended to encourage the development of innovative medical devices, be customized additive manufacturing for the applicant (or simply ‘3D Print’) Medical Devices the registration application to provide technical guidance, as well as food and drug administration departments to provide technical reference for the review of registration dossiers.”

In addition to addressing industry questions, this guidance also proposes some specific requirements for the testing and validation of any 3D printed medical device products that are submitted to the CFDA for approval.

3D printed hip implant [Image: GE]

This new guidance covers 3D printed medical device implants for dental and orthopedic applications, along with 3D printed biomaterials and pharmaceuticals.

“This guidance does not cover all the requirements of medical devices specially designed a pharmaceutical composition comprising, cells, tissues and other biologically active substances in biological 3D printing, but can refer to the specific requirements of the applicable requirements,” the translated draft guidance states.

There are a variety of important regulatory proposals set out in the new CFDA guidance, such as requiring validation testing for all 3D printing equipment, materials, processes, software, and final products. It also states that product validations should include anti-pull strength and fatigue tests, usability tests, functionality testing and evaluation, and any components related to these.

The CFDA guidance proposes that clinicians and healthcare professionals should be involved in the decision-making for both the design input and output for 3D printed medical devices, and that environmental parameters for 3D printing must be defined in order to include energy density, gas composition, humidity, pressure, 3D printing speed, temperature, and other related factors.

Additionally, the guidance states that additive manufacturers should be required to conduct cleaning processes for complex 3D printed medical devices themselves, and not outsource them to other companies. The effectiveness of the chosen cleaning method must also be demonstrated.

“For products sterilized by irradiation, irradiation dose required to clear and relevant validation report,” the translated guidance says.

There is also a section on the use of animal models for testing 3D printed medical implants. Finally, the CFDA’s new draft guidance says that the use of 3D printed medical implants needs to involve contracts between the manufacturer, the healthcare provider, and the patient.

Right now, the CFDA is looking for comments from the industry in regards to its new guidance.

The CMDE says, “In order to make the Guiding Principles more scientific, reasonable, and practical, we will publicly solicit opinions on our website from now on. We sincerely hope that experts, scholars, managers, and practitioners in relevant fields can provide constructive suggestions or suggestions and promote guidance. The enrichment and improvement of principles will promote the quality and efficiency of registration declarations and technical reviews.”

Once all stakeholder comments have been received and compiled, the CFDA will issue a final version of its guidance.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts below.

[Source: Emergo]

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Taking it to the Streets With Addibot: Mobile 3D Printers May Eliminate Pothole Issues Forever

UntitledPotholes are just such a rude little surprise. Sending your morning coffee sloshing and your teeth gnashing on the fast track to work, they can also cause actual damage to your car–and take a nasty bite out of your wallet. It would seem that some of the world’s brightest minds would have set their sights on eliminating these gnarly little road hazards sooner.

Happily roving bots sound like the perfect answer for today though. And Robert Flitsch is making it his goal to put them to work, performing tasks that most humans probably really don’t want to do. It’s surprising how inconveniences we’ve dealt with nearly our entire lives may soon simply be eliminated due to innovations allowed by 3D printing–if Flitsch, a recent Harvard grad, gets his way. His machines, referred to as Addibots, should be out on the streets soon, once designs are finalized and sufficient funding procured.

The Addibot is, in its simplest form, a mobile 3D printer. The concept of indoor machines stuck in workshops pumping out components doesn’t do much for fixing our vast roadways–but releasing them from those constraints and putting machines like the Addibot out into the fresh air to clean up battered pavement opens up a whole new world of ideas for fabrication.

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The Addibot working its magic on ice

The robot operates just like a traditional 3D printer, scaled down and made to weather the elements. Flitsch has designed it for dual controls, via remote operation or completely automated.

“One of the main limitations with 3D printers is you typically have it printing inside this box, and you can really only print objects of the size of the workspace you’re printing in,” says the 22-year-old Flitsch, a mechanical engineer who graduated from the Harvard John A. Paulson School of Engineering and Applied Sciences last May. “If you take additive manufacturing implements and make them mobile, you can print objects of arbitrary size.”

The mobile concept involves ‘all systems on board,’ with multiple nozzles which would be used to fill in and pave over potholes. Flitsch has tested this with some very interesting material: icy water. As a hockey player himself, he was inspired to try the Addibot on ice with his ‘Ice Resurfacing Addibot,’ allowing his pet bot to pour water into the slices and cuts made by players’ skates. The concept is brilliant in its simplicity, as the water would simply freeze, smoothing out the surface of the ice perfectly. And translating it to the road makes perfect sense.

UntitledThe goal with asphalt is in making sure the correct measurements are applied to fix potholes. With that in place, Flitsch says that repairs could be done at a consistent speed around a few miles per hour. Finding a way for the robot to manipulate tar accordingly is a stickier subject, and a work in progress. Other considerations come into play as well once you are taking your 3D printing outside, such as particles like dust causing interference. This can be dealt with due to a stronger undercarriage. Power is of course a main issue that has to be dealt with also.

“All the storage for material, all the chemical processing could be done on board the Addibot,” he says. “Tar materials, which have to be kept at a high temperature, can be done in a tank with a constant heat source added to it. Power sources could be various kinds, depending on the size of the robot.”

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With one prototype already under his belt, Flitsch will require funding to keep working on R&D with different materials–and he sees that as having nearly unlimited potential.

“The only way that I see Addibots being limited is in whatever materials we can think up to use,” he says.

We think many will be behind this idea for not only fixing messy potholes and other infrastructure issues, but also in embracing the idea of taking away the indoor constraints from 3D printing and allowing for ‘making the world a makespace.’